Pilot Testing Dementia-Enhanced Training and Tool for Home Hospice Clinicians: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pilot Testing Dementia-Enhanced Training and Tool for Home Hospice Clinicians (NCT05719077), a randomized na study. The primary outcome is Family Caregiver Burden.

2. Clinical Question

The study was a pilot evaluation of feasibility, acceptability, and preliminary efficacy, not simply a test of a single outcome. The primary outcome was caregiver burden; clinician knowledge was a secondary outcome. The registry also describes exploratory expectations concerning caregiver self-efficacy and preparedness and patient live discharges. Results for those exploratory outcomes are not reported in the registry record. The posted primary comparison is based on caregivers with both baseline and follow-up data, rather than everyone enrolled in the trial.

3. Trial Design

The registry identifies NCT05719077 as a completed, randomized, parallel-group study with no masking. Rutgers, The State University of New Jersey, is listed as sponsor. The study began on 2023-10-06, had a primary completion date of 2025-06-30, and enrolled 93 participants. The trial was designed as a pilot of dementia-enhanced training and a tool for home hospice clinicians.

Clinicians, rather than individual caregivers, are described as belonging to the intervention or control group. Intervention clinicians received video-based education and used the assessment tool with family caregivers during regular home visits. Control clinicians listened to a presentation about outcomes for home hospice patients living with dementia. The registry does not report the allocation procedure beyond identifying the study as randomized, nor does it report further details of the presentation or training schedule.

The primary outcome was caregiver burden, assessed in family care partners at baseline and at the first subsequent hospice visit, an average of 8 weeks. The registry says the primary analysis included family care partners in both groups who provided data at baseline and after that visit. It also notes that caregivers might not complete all four data-collection time points because patients may die and home visits may then stop. The primary outcome results include 26 intervention caregivers and 15 control caregivers.

Clinician knowledge of dementia-related issues at end of life was the posted secondary outcome. It was assessed from baseline through training completion, an average of 4 weeks. That result includes 13 intervention clinicians and 14 control clinicians. The registry lists five outcome measures and three analyses, but further outcome results are not reported in the registry record. Details of the randomization method, allocation concealment, and whether analyses accounted for clustering of caregivers within clinicians are not reported in the registry record.

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.

Before assignment: No enrolled participants were excluded from the study before assignment to a study group.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Assessed for FCP only. Includes FCP in intervention and control groups who provided data at baseline and following first subsequent hospice visit.

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: 29 clinicians were enrolled and randomized to intervention (n=15) or control (n=14) groups. 1 intervention clinician was lost to follow up before providing any baseline data. 64 FCP were enrolled and randomized to intervention or control groups. Of 37 in the intervention group, 35 contributed some baseline data, 1 dropped out, and 1 became ineligible before baseline data were collected. Of 27 FCP in control group, 26 contributed some baseline data, 1 dropped out, and 1 was lost to follow-up.

6. Primary Endpoint

The registry lists the primary outcome as Family Caregiver Burden, measured over Baseline and through first subsequent hospice visit, an average of 8 weeks.

The primary endpoint was change in family caregiver burden from baseline to the first subsequent hospice visit. Burden was assessed with the validated 12-item Zarit Caregiver Burden Inventory. Summed scores range from 0-48, and higher scores indicate greater burden. The registry describes the outcome as a change in score on a scale and gives the assessment period as baseline through the first subsequent hospice visit, an average of 8 weeks.

Change scores allow the comparison to focus on how reported burden shifted over the follow-up period, rather than only comparing the groups' scores at one time. The study's stated expectation was that caregivers linked to intervention clinicians would report less burden than caregivers linked to control clinicians. For this scale, a decline in score is consistent with lower burden; an increase is consistent with greater burden. That directional interpretation does not establish why a score changed or whether a change is important to caregivers.

The registry says the primary comparison was between changes in the two groups. It identifies the primary analysis population as family care partners who had data at both baseline and the first subsequent hospice visit. The posted outcome gives group mean changes and standard deviations, but does not give a confidence interval or an estimated between-group difference for this primary comparison. The sponsor's reported analysis is a two-sided t-test with p = 0.14.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is continuous: caregiver burden is represented by a summed scale score, and the reported group values are mean changes with standard deviations. A mean describes the average change among participants in a group. A standard deviation describes the spread of individual changes around that group mean; it is not a confidence interval and does not directly describe uncertainty in the group mean.

What does the t-test assess?

The registry reports a two-sided t-test for the primary comparison. In general, a two-sided t-test evaluates whether the data are compatible with equal group means while allowing for a difference in either direction. Its p-value is calculated under a null hypothesis and the test's assumptions. It is not the probability that the null hypothesis is true, and it does not tell readers how large or clinically important a difference may be. The primary p-value is 0.14. The record does not report a primary between-group estimate or confidence interval, so the test result cannot be paired with a posted interval showing the uncertainty in the size of the primary contrast.

What does a confidence interval add?

In general, a confidence interval gives a range of estimates compatible with the data and the method used to calculate it. For clinician knowledge, the unadjusted recalculation reports a mean difference of 2.8 and a 95% confidence interval from -1.391 to 6.991. Because that interval includes zero, it does not distinguish clearly between a positive difference, no difference, or a negative difference at the conventional two-sided 0.05 level. The breadth of the interval also signals uncertainty about the size of the difference. It is not a range guaranteed to contain the true effect, and it does not address bias or limitations in the analysis population.

Why can group summaries and tests differ?

A recalculation based on posted summary statistics uses an unadjusted comparison of the group means and standard deviations. It does not include participant-level data or any adjustment that may have been used in the sponsor's analysis. The secondary recalculation uses the posted group means, standard deviations, and sample sizes. Its standard error is based on those summaries and the stated unadjusted comparison. A sponsor analysis may use another method or analysis population, but the details needed to establish that are not reported in the registry record. Therefore, the recalculation is a transparent check based on summary data, not a replacement for a fully described sponsor analysis.

The recalculated standardized effect for clinician knowledge uses the difference in group means divided by a pooled standard deviation. In general, standardizing an effect expresses a mean difference relative to the variability in the observed measure. It can help describe scale-independent magnitude, but it does not establish clinical importance. The recalculated standardized effect is 0.501 to three decimal places; it remains an estimate from small groups and should be read alongside the confidence interval and the underlying score changes.

How should the planning illustrations be read?

The sample-size planning illustrations are based on the observed clinician-knowledge effect, not the original trial design. They use a two-sided significance level of 0.05, equal allocation, and a normal approximation. They estimate participants per arm for 80% or 90% power when planning for 100%, 75%, or 50% of the observed effect. For 100% of the observed effect, the illustrations give 63 participants per arm for 80% power and 84 for 90% power. For 75%, they give 112 and 149 participants per arm, respectively; for 50%, they give 250 and 335. These are planning illustrations conditional on the stated assumptions, not observed power, a justification of the trial's enrollment, or a guarantee of a future result.

In general, power is the probability that a specified analysis will reject a null hypothesis when a particular effect and set of assumptions are true. Calculating a post hoc power value from an observed effect does not add information beyond the estimate, uncertainty, and test result. The registry does not report the original sample-size justification or the assumptions used to plan enrollment, so the illustrations cannot be taken as the study's prespecified design calculation.

What are the limitations of summary-data methods?

The recalculations cannot assess the distribution of individual scores, influential observations, or departures from model assumptions. They also cannot account for covariates, clustering, repeated measurements, or missing-data methods unless these are reflected in the posted summary statistics. General statistical practice treats such choices as important because they can affect standard errors, estimated effects, and the interpretation of p-values. Whether any of these approaches were used for the sponsor's analyses is not reported in the registry record.

The posted primary outcome is a change score and the stated test is a t-test. The registry does not give enough detail to determine the precise implementation of that test, including variance assumptions or any adjustment. The clinician-knowledge recalculation is likewise an unadjusted comparison. Its interval and p-value should be understood as results of that simple method, not as a reconstruction of an analysis plan that is not described in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Intervention Family Care Partners (FCP)", "Control Family Care Partners")
n   <- c(26, 15)
m   <- c(-1, 0.4)
sp  <- c(3.5, 4.6)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Intervention Family Care Partners (FCP)  26  -1.000  3.500  -2.414  0.414
CARM  Control Family Care Partners  15  0.400  4.600  -2.147  2.947

11. Analyses Reported by the Sponsor

For caregiver burden, the registry reports the sponsor's two-sided t-test with p = 0.14. It does not report the corresponding between-group estimate or confidence interval. The group summaries are a mean change of -1.0 (standard deviation 3.5) for 26 intervention caregivers and 0.4 (standard deviation 4.6) for 15 control caregivers. The registry record does not provide enough information to reconstruct the sponsor's primary test from participant-level data, so the posted p-value should be read as the sponsor's reported analysis and the means as descriptive group results.

For clinician knowledge, the sponsor's reported two-sided test has p = 0.90. A separate unadjusted recalculation from the posted group means, standard deviations, and sample sizes gives a mean difference of 2.8, a 95% confidence interval from -1.391 to 6.991, and p = 0.19. This recalculation is not the sponsor's analysis and cannot establish which analytic choices account for the difference between the p-values. The registry does not report the details needed to reconcile them, such as any adjustment or analysis-population distinction. The registry's discrepancy indicator is false, but that does not supply the missing methodological detail. The sponsor's reported result and the recalculation should therefore be identified separately rather than blended into a single estimate.

12. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary outcome and a secondary outcome, and its study summary additionally mentions exploratory expectations. It does not report a multiplicity procedure, an ordered testing strategy, or which analyses were designated as confirmatory beyond the primary outcome description. Without this information, the extent to which the sponsor accounted for multiple outcomes or comparisons is not reported in the registry record.

In general, testing multiple hypotheses without adjustment raises the chance of at least one result appearing statistically notable by chance. A prespecified primary outcome can help focus interpretation, while secondary and exploratory findings are usually interpreted more cautiously, especially if they are not adjusted. That general principle does not establish that any particular result in this trial is false; it describes why isolated secondary p-values should not be treated as definitive. The registry's reported p-values are two-sided, but the analysis plan and multiplicity approach are not reported in the registry record.

The primary analysis population included caregivers with measurements at baseline and at the first subsequent hospice visit. The registry notes that some caregivers might not complete all four time points because a patient's death could end home visits. The number of participants with missing outcome data at each time point, the reasons for missingness, and the statistical method for handling missing data are not reported in the registry record. The primary population description shows that complete observations at the two specified assessments were required for inclusion, but it does not establish how missing outcomes may have affected the comparison.

The registry reports enrollment of 93, while the primary caregiver result includes 26 intervention and 15 control family care partners. These counts relate to the posted primary analysis, not necessarily the number initially enrolled in each group. A detailed flow of participants from enrollment to analysis is not reported in the registry record. It also does not report whether the analysis followed an intention-to-treat principle, how clinician-level randomization was handled statistically, or whether caregivers clustered under the same clinician were accounted for. Those details matter because the observations may not be statistically independent if multiple caregivers are associated with a clinician.

13. 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 adverse-event record lists zero serious adverse events and zero deaths among the clinician and family care partner groups shown. The groups at risk are 15 intervention clinicians, 14 control clinicians, 37 intervention family care partners, and 27 control family care partners. For each listed group, the count affected by a serious adverse event is zero; the count affected by other adverse events is also zero.

These figures describe the event counts recorded in the registry for the populations at risk. They do not establish that no events occurred outside the registry's reporting definitions or observation period, and they do not show whether event monitoring was complete. The event-reporting timeframe and further details of collection or attribution are not reported in the registry record. The adverse-event group counts also differ from the analyzed primary-outcome counts, so they should not be treated as the numbers contributing to the caregiver-burden comparison. The figures are a safety-reporting summary, not evidence that the intervention has no risks.

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

The primary result describes caregiver-burden changes among the family care partners who had baseline and first-follow-up data. The intervention group mean change was -1.0 and the control group mean change was 0.4; the sponsor-reported two-sided comparison has p = 0.14. The group averages point in different directions, but the registry does not give an estimated between-group contrast or confidence interval for the primary outcome. Therefore, the size and precision of the comparative effect cannot be fully characterized from the posted primary result.

The result does not establish that the training and tool reduced caregiver burden, nor does it establish that they had no effect. A p-value above a conventional threshold is not proof of equality. The data available in the registry record leave uncertainty about the primary comparison, compounded by the limited analysis population and the absence of details about missing-data handling.

The clinician-knowledge result is also preliminary. The unadjusted recalculation indicates an estimated mean difference of 2.8, with a 95% confidence interval from -1.391 to 6.991, while the sponsor-reported p-value is 0.90. The registry record does not explain the difference between those analyses. This secondary result should not be interpreted as evidence of a confirmed knowledge change or as a definitive test of the primary outcome.

The study's stated purpose was to pilot feasibility, acceptability, and preliminary efficacy. The registry record does not report findings for feasibility or acceptability, or results for the exploratory outcomes it describes. No conclusion about those outcomes follows from the posted burden and knowledge statistics alone. More broadly, statistical findings do not by themselves establish whether an intervention is suitable for a particular patient, caregiver, or care setting; this interpretation is limited to the reported study outcomes and analyses.

15. Why This Trial Matters Statistically

This trial raises statistical issues common to pilot studies in clinical and community settings. The intervention is delivered through clinicians, while caregiver outcomes are measured among people connected to those clinicians. That structure makes it important to know how randomization was implemented and whether analyses account for possible clustering. Those methods are not reported in the registry record, so readers cannot determine their influence on uncertainty estimates.

The primary endpoint also depends on follow-up in a population where visits may stop when a patient dies. The registry acknowledges that not all caregivers may complete all four measurement points and defines a primary analysis population with observations at baseline and the first subsequent visit. This makes the distinction between enrolled participants and analyzed participants particularly important. Transparent participant-flow and missing-data reporting would help readers assess selection and the scope of the result.

Finally, the posted primary result includes group summaries and a p-value but no between-group estimate or confidence interval. A test alone gives limited information about the size and precision of a clinical comparison. The secondary knowledge result illustrates why methods should be reported clearly: the sponsor's reported p-value differs from the simple recalculation based on group summaries, yet the registry record does not explain the analytic details. These are not merely technical niceties. Estimates, intervals, populations, and analysis choices determine what can reasonably be inferred from a pilot and how its findings can inform later research planning.

16. 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 registry record leaves several trial-specific limitations unresolved. For the primary outcome, the analyzed caregiver counts are 26 in the intervention group and 15 in the control group, while total enrollment is 93. The record describes eligibility for the primary analysis but does not provide a complete flow explaining the difference between enrollment and the outcome sample. It also does not report the primary between-group estimate or confidence interval, limiting interpretation of the effect's magnitude and precision.

Follow-up may be affected by patient death, which the registry identifies as a reason caregivers may not complete all four collection points. The exact missing-data pattern and its handling are not reported in the registry record. In addition, clinicians are grouped by intervention, while caregivers provide the primary outcome. Whether statistical analyses account for the relationship between caregivers associated with the same clinician is not reported. The randomization procedure and allocation concealment are also not described beyond the randomized designation.

The reported intervention description is incomplete: the control description ends before all details are available, and the intervention description does not provide a complete account of the training content or delivery. The registry does not report adherence to the videos or tool, implementation fidelity, or results for feasibility and acceptability. It describes exploratory outcomes but does not report their results. Nor does it explain the discrepancy between the sponsor's secondary p-value and the unadjusted recalculation. These gaps limit evaluation of implementation, analysis choices, and the breadth of findings beyond the posted outcomes.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: Pilot Testing Dementia-Enhanced Training and Tool for Home Hospice Clinicians — NCT05719077.
• Registry record last updated 2026-07-16; status last verified 2026-07.
• Results first posted 2026-07-16.
• 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.

20. Record Summary

NCT05719077 is a completed randomized, unmasked, parallel-group pilot study sponsored by Rutgers, The State University of New Jersey. It enrolled 93 participants and evaluated dementia-enhanced training and a caregiver assessment tool for home hospice clinicians. The primary outcome was caregiver burden, assessed from baseline to the first subsequent hospice visit, an average of 8 weeks.

Among family care partners with the required observations, mean change was -1.0 (standard deviation 3.5; 26 participants) in the intervention group and 0.4 (standard deviation 4.6; 15 participants) in the control group. The registry reports a two-sided primary comparison with p = 0.14, without a between-group estimate or confidence interval. The posted secondary outcome concerns clinician knowledge; its sponsor-reported test gives p = 0.90, while the unadjusted summary-statistic recalculation gives a mean difference of 2.8 and a 95% confidence interval from -1.391 to 6.991. Further results and important analysis details are not reported in the registry record.