Study of the Aliviado DSD Caregiving Mastery Program: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of the Aliviado DSD Caregiving Mastery Program (NCT05630014), a na na study. The primary outcome is Number of Participants Who Complete the Study.

2. Clinical Question

The study addresses whether a family-centered program can be developed and piloted to support family caregivers in detecting, preventing, and managing delirium superimposed on dementia (DSD). Its aims include adapting education and an mHealth app for family caregivers, then assessing feasibility, acceptability, app usability, and preliminary program impact. The primary endpoint focuses specifically on completion of the study by caregivers.

This is a feasibility and early piloting question, not a randomized comparison of the program with another intervention or usual care. The registry describes a co-design process with 8 family caregivers and a separate pilot of the full program. The planned program addresses caregiver tasks related to DSD, while the listed secondary outcomes include knowledge, strain, depressive symptoms, burden, competence, and self-efficacy. The record does not report whether the pilot met its completion target or what changes occurred on the secondary measures. Consequently, the clinical question can be described from the study aims and endpoint definition, but the posted results do not establish the magnitude or precision of any program-related change.

3. Trial Design

The study, NCT05630014, is titled “Study of the Aliviado DSD Caregiving Mastery Program.” Its official title describes development and piloting of a family-centered, mHealth-enhanced intervention to promote caregiving mastery in detection, prevention, and management of DSD. NYU Langone Health is the sponsor. The registry status is completed, with a start date of 2023-12-20 and primary completion date of 2025-02-11.

The study has two linked aims. The first is development through a 5-week co-design workshop with 8 family caregivers. The planned work adapts clinician-centered DSD content and an mHealth app from the Aliviado Dementia Care program for family caregivers. The second aim is pilot testing the full program with family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact. Overall enrollment is 33, while the primary endpoint description identifies an analysis population of all eligible enrolled primary family caregivers (n = 30). The record does not explain the relationship between these enrollment figures.

The registry identifies the intervention as behavioral and the study model as single group. Masking is listed as none, and allocation is listed as NA. The arm description says participants complete the program: caregiver education and training from Week 0 to Week 2, followed by implementation from Week 3 to Week 6. There is no like-for-like control arm described, so the study is not a randomized treatment comparison. The phase is listed as NA. Details about a formal protocol, sample-size justification for the pilot, or a statistical analysis plan are not reported in the registry record. The design is most appropriately understood as development plus single-group feasibility piloting, with a completion count as the primary outcome.

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: Focus Groups were conducted in Aim 1 with 8 family caregivers to develop the program. These participants were not considered enrolled for the purposes of this study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All eligible enrolled primary family caregivers (n = 30) were analyzed.

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: Of the 32 consented primary family caregivers, 2 did not meet the eligibility criteria and were excluded from all data analyses.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants Who Complete the Study, measured over Week 6.

The primary endpoint is the number of participants who complete the study by Week 6. The registry describes this as a measure of feasibility and identifies a retention rate of 85% as the feasibility indicator. The primary endpoint analysis population is all eligible enrolled primary family caregivers (n = 30). However, the observed number completing the study and the observed retention result are not reported in the registry record.

Completion is useful in an early pilot because it addresses whether participants remain engaged through the scheduled study period. This is distinct from whether a program changes caregiver knowledge, burden, or other outcomes. A completion count can inform practical feasibility, but on its own it does not quantify the program’s effect on those other measures, establish the reasons participants did or did not complete, or demonstrate comparative benefit. The record does not report how completion was defined beyond the endpoint title and Week 6 timeframe, or how participants with incomplete follow-up were classified.

General: A count is a descriptive endpoint: it records how many participants meet a stated condition. For interpreting a count as a retention rate, the denominator and handling of participants with missing status need to be clear. Here, the registry gives an analysis population and a target retention rate, but does not report the observed count or the operational details needed to independently assess the rate. Therefore, the endpoint’s purpose and intended feasibility threshold can be described, while whether the pilot achieved that threshold remains unknown from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design and endpoint call for a descriptive reading. The study is listed as single group, with no allocation to a comparator and no masking. Its primary endpoint is a participant count at Week 6, while the study also lists caregiver-reported measures at specified follow-up times. No analysis results are reported in the registry record, so there are no posted effect estimates, confidence intervals, or test statistics to interpret.

What a single-group design can describe

General: A single-group design observes participants who receive the intervention without a concurrent comparison group. It can describe participation, completion, usability, acceptability, and measured outcomes among the enrolled group. When outcomes are collected at multiple times, the design can also describe within-participant change if those results are reported. However, a change over time does not by itself show that the intervention caused the change. Other influences, including ordinary variation over time and changes in participants’ circumstances, may also contribute. A concurrent comparator helps address this limitation by showing what happened in a group not assigned to the intervention under the study’s comparison framework.

The study record identifies the program as a behavioral intervention and describes an education and training period from Week 0 to Week 2, followed by an implementation period from Week 3 to Week 6. These phases explain the scheduled program activities, not a randomized contrast. The record lists masking as none and allocation as NA. The record does not report a statistical plan for repeated measurements or a method for adjusting for any participant characteristics.

How to read a completion count

General: A count reports the number of people meeting an endpoint definition. The count is easiest to interpret when the endpoint definition, eligible population, follow-up period, and handling of missing status are explicit. For a feasibility measure framed as retention, the denominator matters: a count alone cannot identify the proportion retained unless the relevant population is clear. The endpoint description gives the analysis population as all eligible enrolled primary family caregivers (n = 30) and names Week 6 as the assessment time. It also states that a retention rate of 85% indicates feasibility. The registry record does not report the observed number completing the study, the observed retention rate, or the detailed classification rules used for incomplete records.

A confidence interval, when reported, describes statistical uncertainty around an estimate under the method used to calculate it. It is not a guarantee that the true value lies within the interval, nor does it describe all sources of uncertainty such as bias from missing observations or the absence of a comparator. No interval for completion or other endpoint is reported in the registry record. Therefore, precision cannot be assessed from an interval, and the target retention criterion should not be confused with an observed estimate.

Counts, estimates, and uncertainty

The registry classifies the primary outcome as a count of participants with an event, where the event is study completion. For a binary outcome, each participant is classified according to whether the event occurred. A count and a proportion answer related but distinct descriptive questions: the count gives the number meeting the condition, while a proportion relates that count to a defined group. The posted endpoint identifies its intended analysis population, but its observed result is absent in the registry record for interpretation.

General: Statistical testing is often used to assess how compatible data are with a specified null hypothesis under an analysis model. A p-value is not the probability that a hypothesis is true, and a small p-value does not quantify clinical importance. For this pilot, no inferential analysis results are reported in the registry record. There is consequently no basis for discussing statistical significance, nor for treating the stated feasibility criterion as if it were a hypothesis test.

Planning calculations and their scope

General: Sample-size planning uses assumptions about the effect to detect, variability, allocation, significance level, and desired power. Such calculations describe a hypothetical design under those assumptions; they do not report observed outcomes or the probability that a completed study has demonstrated an effect. In particular, “observed power” is not a substitute for an estimate and its uncertainty.

The sample-size illustrations associated with this record are described as planning calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are hypothetical two-arm planning assumptions, whereas the registry describes the actual study as single group. The illustrations therefore do not change the design classification, establish that the study was powered for a two-arm comparison, or serve as evidence of an intervention effect. The registry record does not report a trial-specific sample-size justification, and the actual sample-size planning rationale is not reported in the registry record.

Overall, the statistical interpretation is constrained by the absence of reported outcome estimates and analysis details. The design supports a feasibility-oriented description, but there is no posted numerical result from which to assess completion, change, or precision. Any explanation of statistical concepts in this context is general and should not be mistaken for a result from this study.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Family Caregivers of PLWD at High Risk for Deliriu")
n      <- c(30)
events <- c(26)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Family Caregivers of PLWD at High Risk for Deliriu  30  26  86.7  69.3  96.2  70.3  94.7  70.2  94.5

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 15 outcome measures, including the primary completion endpoint and secondary measures covering caregiver delirium knowledge, strain, depressive symptoms, burden, caregiving mastery competence, and self-efficacy. Several caregiver measures are assessed at more than one scheduled time. This creates multiple outcome questions, but the registry record does not report a strategy for controlling multiplicity, such as prioritizing a limited set of comparisons or adjusting interpretation across tests. No analysis results are reported in the registry record, so there are no reported significance tests to evaluate for multiplicity.

General: When many outcomes or time points are examined, the chance of encountering an apparently unusual result can increase if each is treated as a separate confirmatory test. Adjustment procedures or a prespecified hierarchy can help define how such results should be interpreted. In an exploratory pilot, outcomes may instead be used descriptively to guide refinement and later study design; that purpose should be distinguished from confirmatory testing. The registry does not report which approach was planned.

Missing-data methods are also not reported in the registry record. The endpoint specifies an analysis population of all eligible enrolled primary family caregivers (n = 30), but that statement does not explain how missing Week 6 completion status or missing questionnaire responses were handled. The record does not report whether any imputation, complete-case analysis, or other procedure was used, nor does it state the amount or pattern of missing data.

The study description does not report detailed analysis populations for each secondary outcome. It is therefore not possible to determine whether all enrolled participants contributed to each measure, whether populations differed by outcome, or how incomplete follow-up affected the reported analyses. The number of analyses is listed as zero, and there are no inferential results in the registry record to assess. These omissions limit assessment of multiplicity, missingness, and the relationship between the intended outcomes and the analyzed data.

12. 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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: emergency room visit (3.8%).

The registry lists safety information for the group “Family Caregivers of PLWD at High Risk for Delirium.” For serious adverse events, 26 participants were at risk and 1 was affected. For other adverse events, 26 participants were at risk and 4 were affected. Deaths are listed as 0. Emergency room visit is the leading serious adverse event term, reported as 3.8%.

These entries should be read as descriptive counts for the registry’s listed categories, not as evidence from a comparison between intervention and control groups. The study is single group, and no comparator is described. The registry record does not report an attribution assessment indicating whether an event was considered related to the program, nor does it provide event narratives or timing details. The record also does not explain whether the number of participants at risk differs from the enrollment total because of safety-specific eligibility or follow-up.

General: An adverse-event count records events or affected participants according to the registry’s reporting structure. Serious and non-serious events are distinct reporting categories, and the number of affected participants is not necessarily the same as the number of event episodes. A reported event does not by itself establish causation. Without a comparator, detailed event context, and an attribution framework, these figures cannot establish whether the program increased or decreased risk. The listed counts and percentage describe the posted safety information only; they do not resolve causal questions about safety.

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

The record establishes that a family-centered program was developed and piloted, and it identifies study completion by Week 6 as the primary feasibility endpoint. It also states that a retention rate of 85% was the intended feasibility indicator. The record does not report the observed completion count or retention rate, so it does not establish whether the pilot reached that indicator. The secondary outcomes show which caregiver domains were designated for assessment, but their numerical results are not reported in the registry record.

The study’s single-group structure is important to interpretation. Participants completed the program, but there is no concurrent comparison group described. Therefore, even if changes in caregiver measures were available, changes alone would not establish that the intervention caused them. The registry record does not report results with which to evaluate those changes in any case. The study is described as a pilot with aims that include feasibility, acceptability, app usability, and preliminary program impact; these aims should not be treated as conclusions about success or effectiveness.

The record also does not provide statistical estimates or uncertainty intervals. As a result, the precision of the primary endpoint and secondary outcomes cannot be assessed. The total enrollment of 33 and the primary endpoint population of n = 30 are both stated, but the reason for the difference is not reported in the registry record. No inference should be made about participant disposition from those figures alone.

The safety entries report affected participants and a leading serious adverse-event term, but they do not offer a randomized safety comparison or enough context to attribute events to the program. Likewise, the sample-size planning illustrations use assumptions for a hypothetical two-arm design and are not evidence from a two-arm trial. The overall meaning is consequently narrow: the record describes intervention development, a single-group pilot design, intended outcomes, and selected safety counts. It does not establish a comparative treatment effect, a causal effect, or whether the stated feasibility criterion was met.

14. Why This Trial Matters Statistically

Feasibility studies address a different statistical question from efficacy trials. Before interpreting a program’s impact, researchers may need to know whether the intervention can be delivered, whether participants engage with it, whether study procedures are workable, and whether the planned outcomes can be collected. This study’s stated focus on completion, acceptability, app usability, and preliminary impact fits that early-stage role. The primary completion endpoint targets an operational question: whether eligible enrolled caregivers remain through the study’s Week 6 assessment.

The record is also statistically informative as an example of why aims and results must be separated. The stated retention rate of 85% is a criterion for feasibility, not the observed retention result. The endpoint identifies an analysis population of n = 30, while overall enrollment is 33; without an account of participant flow, those figures cannot be reconciled. Clear reporting of the number enrolled, eligible, followed, and completing would make a feasibility result easier to interpret.

A single-group pilot can support descriptive learning about implementation and outcome collection, but it does not provide a direct comparison against another group. That limitation is especially important when readers encounter planning calculations framed around equal allocation to two arms. Those calculations are illustrations under hypothetical assumptions, not a description of the actual single-group design and not a substitute for observed results.

The study’s listed outcome domains also show that feasibility and preliminary impact involve more than one measure. Reporting how outcomes were selected, how missing responses were handled, and whether analyses were exploratory or confirmatory would help readers understand the scope of the evidence. Such details are not reported in the registry record. The central statistical value of this record is therefore its description of a development-and-pilot framework, while its missing outcome estimates prevent appraisal of the pilot’s observed feasibility or preliminary changes.

15. 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 for interpreting results is that the registry record does not report the observed primary completion count or retention rate. Although it identifies the feasibility indicator as a retention rate of 85% and gives the primary endpoint analysis population as n = 30, it does not state how many participants completed the study. It is therefore not possible to judge whether the stated criterion was reached.

Overall enrollment is 33, while the primary analysis population is described as all eligible enrolled primary family caregivers (n = 30). The registry record does not explain the difference, provide a participant flow account, or describe exclusions and withdrawals. It also does not report the operational definition of completion beyond the endpoint title and Week 6 timeframe.

The design is single group, with no allocation to a comparator and no masking. As a result, the study does not support a randomized between-group comparison. The record does not report outcome estimates for the listed caregiver measures, uncertainty intervals, or inferential analyses. The statistical analysis plan, multiplicity approach, and missing-data methods are not reported in the registry record. The number of listed outcome measures is 15, but detailed results and analysis populations for those outcomes are absent.

The study description combines a co-design process and a pilot, while the record does not provide detailed outcome results separately for each aim. Acceptability and app usability are stated as pilot assessment aims, but numerical results for those domains are not reported in the registry record. Safety figures are descriptive and lack a comparator, event narratives, and reported attribution details. These limitations mean that the registry record can describe the design and planned assessment, but cannot support a conclusion about observed feasibility, outcome change, causal impact, or comparative safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Study of the Aliviado DSD Caregiving Mastery Program — NCT05630014.
• Registry record last updated 2026-02-10; status last verified 2026-01.
• Results first posted 2026-02-10.
• 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.

19. Record Summary

NCT05630014 is a completed single-group study sponsored by NYU Langone Health. It developed and piloted the Aliviado DSD Caregiving Mastery Program for family caregivers of PLWD at high risk for delirium. The development aim involved a 5-week co-design workshop with 8 caregivers; the pilot involved caregiver education and training from Week 0 to Week 2 and implementation from Week 3 to Week 6.

Overall enrollment was 33. The primary endpoint was the number of participants completing the study at Week 6, with a stated feasibility indicator of a retention rate of 85%; the endpoint analysis population was all eligible enrolled primary family caregivers (n = 30). The observed completion result and secondary outcome results are not reported in the registry record. The record lists 15 outcome measures and descriptive safety counts, but no inferential analysis results.

The design supports a feasibility-oriented description, not a randomized comparison. Details on the statistical analysis plan, missing-data handling, and multiplicity are not reported in the registry record.