Our Care Wishes - Dementia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Our Care Wishes - Dementia (NCT05033262), a randomized na study. The primary outcome is Adapted Decision Making Confidence Scale.

2. Clinical Question

The study's stated purpose was to adapt the platform and assess usability and acceptability among nursing home residents and SDMs. The registry does not report a posted usability or acceptability outcome among its primary results. The primary endpoint instead records decision-making confidence at baseline, before the intervention website review described for the intervention group.

The registry describes randomized allocation, with parallel groups and double masking recorded. However, the record does not explain who was masked or how masking was implemented. The enrollment is 14, and the posted baseline scale results are separated by both role and assigned group. This makes the displayed summaries descriptive for PLWDs and SDMs in their respective groups, rather than a single combined comparison of intervention and control.

3. Trial Design

This was a completed pilot study of an adaptation of the OurCareWishes.Org advance care planning platform for persons living with dementia in nursing homes and their caregivers. The intervention is named Our Memory Care Wishes. The registry lists the allocation as randomized, the model as parallel, and masking as double. It does not describe the randomization procedure, allocation concealment, or which participants or study personnel were masked; these details are not reported in the registry record.

The enrollment is 14. The registry lists the study start as 2020-10-07 and primary completion as 2021-09-08, with status completed. The phase is listed as not applicable. The sponsor is the University of Pennsylvania. The record describes the participants as nursing home residents and SDMs and lists dementia, Alzheimer disease, and memory impairment among the conditions.

Participants assigned to the intervention completed baseline measures, reviewed the website, and entered advance care planning decisions and preferences. The description says they completed follow-up measures one week after the baseline, but the primary outcome reported in the registry is explicitly at baseline. The control description says participants completed baseline measures and received usual advance care planning care and discussions with nursing facility staff, without reviewing the website. The remaining control follow-up description is incomplete in the registry record.

The stated aim was to adapt the platform and test usability and acceptability. The record does not provide a detailed protocol, eligibility criteria, recruitment process, or a complete schedule of assessments. It also does not report how the pilot's enrollment was chosen or provide a sample-size justification. These omissions limit what can be inferred about the design beyond the recorded group structure, intervention description, and posted baseline 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: Enrolled participants are organized into 4 individual groups: PLWDs \& SDMs in the intervention and control arms. Dyads in all study arms who stopped answering study team calls after initial verbal telephone consent and did not complete the baseline interview were not considered enrolled and are excluded from the "Baseline \& Follow Up Surveys" period below. Demographics were collected during the baseline interview. Nursing home staff were not enrolled in the study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: SDMs and PLWDs in all study arms that completed the baseline interview 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: PLWDs and their SDMs in control and intervention study arms met with study staff and nursing home staff to complete baseline interviews. At baseline, demographics and confidence levels in decision-making were collected for both SDMs and PLWDs.

6. Primary Endpoint

The registry lists the primary outcome as Adapted Decision Making Confidence Scale, measured over Baseline.

The primary endpoint is the Adapted Decision Making Confidence Scale, reported as a score on a scale at baseline. Its items were adapted from the Surrogate Decision-Making Confidence Scale and the 9-item ACP Engagement Survey. The endpoint is intended to capture confidence in advance care planning decision-making from both the PLWD and SDM perspectives.

The scale uses a Likert response format from 1, meaning not confident at all, to 5, meaning very confident. The registry reports a mean score and a full range for each role-and-group entry. It states that the analyzed population comprised SDMs and PLWDs in all study arms who completed the baseline interview. The posted group summaries therefore describe baseline confidence among participants with a baseline interview; they are not follow-up scores or estimates of change.

Confidence is relevant to the study's advance care planning focus because the platform asks participants to consider and enter decisions and preferences. A measure of confidence can describe participants' reported perspective on decision-making. It is not, by itself, a measure of whether plans were completed, whether preferences were followed, or whether the intervention changed confidence. Those interpretations would require outcomes and comparisons that are not reported as the primary endpoint in this record.

The registry does not report a standard deviation or confidence interval for these entries. The listed full ranges give the observed score bounds, but do not show how scores were distributed between those bounds. The endpoint's measurement properties in this adapted population are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean score describe?

A mean is a measure of the average of the recorded scores within a group. For this endpoint, the registry reports a mean for PLWDs and SDMs separately in the control and intervention groups. It can be read alongside the scale's response range, from 1 to 5, where higher scores correspond to greater reported confidence. A mean does not reveal whether most participants gave similar responses or whether a smaller number of unusually low or high responses influenced the average.

Keeping the respondent roles distinct is important for interpretation. The endpoint was designed to represent the perspective of both the person living with dementia and the shared decision-maker. The registry reports separate entries for those perspectives. Combining them would obscure the role-specific results and would require a method and rationale that are not reported in the registry record.

What does the full range show?

The full range reports the lowest and highest values recorded within an outcome group. It describes the span of observed scores, not the uncertainty around the mean. For example, a broad range indicates that observed scores extended across more of the scale; it does not show how many participants had values near either end. A narrow range can mean the recorded scores were similar, but cannot on its own show that the estimate is precise.

General statistical explanation: a confidence interval is an uncertainty summary for an estimate, derived under specified statistical assumptions. It is different from a range of observed individual values. The registry describes the endpoint dispersion as full range and does not report confidence intervals or standard deviations for these means. The reported bounds should therefore be interpreted as score limits, not as an inferential interval.

Why is a baseline result not a treatment comparison?

A treatment comparison typically evaluates an outcome between assigned groups at a defined post-intervention time, or compares how outcomes change from baseline. Here, the primary outcome timeframe is baseline. Although the intervention description refers to follow-up measures one week after baseline, the registry does not post follow-up results for this primary measure. The baseline means can show what was recorded before the described website review, but they do not quantify a response to that review.

Random assignment can support a causal comparison when outcomes and an appropriate analysis are available, but the existence of randomization alone does not turn descriptive baseline summaries into an intervention-effect estimate. The record does not report a formal comparison, a confidence interval for a contrast, or an adjustment model. It also does not describe an analysis plan that would clarify the intended approach.

What does over-dispersion mean in general?

General statistical explanation: over-dispersion occurs when observed variation is greater than a statistical model expects. It can lead to uncertainty estimates that are too small if a model assumes less variability than the data contain. Whether over-dispersion is relevant depends on the outcome type and analysis model. The registry does not report a model or variability estimate that would allow this issue to be assessed for the posted endpoint. The full ranges alone are not a test for over-dispersion.

How should a p-value or interval be read?

General statistical explanation: a p-value describes how compatible observed data are with a specified null model, under the assumptions of the chosen test. It does not measure the size or clinical importance of an effect, and it does not give the probability that the null hypothesis is true. A confidence interval expresses uncertainty about an estimate under a statistical model. Both depend on a defined comparison and analysis. The registry does not report these inferential results for the primary endpoint, so they cannot be used to interpret the baseline means.

The record indicates that values were missing or not estimable for a two-arm comparison for this other endpoint. It is therefore not appropriate to reconstruct a treatment test from the posted group means and ranges. Recalculated contrasts would require assumptions and information not contained in the record, and no recalculated result is presented as a substitute for a sponsor analysis.

What is the role of planning illustrations?

General statistical explanation: sample-size planning asks how much information a future study might need to detect a prespecified effect under stated assumptions. A planning illustration based on an observed effect is not an observed power calculation and does not show the probability that the completed study detected an effect. The registry's stated assumptions refer to a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. Such illustrations are planning tools, not evidence of an outcome.

The registry does not provide an estimable two-arm effect for this endpoint, and the record says the values needed for such a comparison are missing or not estimable. No numerical planning estimate is reported in the registry record for this endpoint. The sample-size assumptions cannot supply a missing treatment estimate or justify an inference from the baseline summaries.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures, but no secondary outcomes are posted in the record. It also lists no analyses. The primary measure is the Adapted Decision Making Confidence Scale at baseline. No multiplicity procedure, hierarchy among outcomes, or plan for controlling the chance of false-positive findings across multiple tests is reported in the registry record. Because no formal comparison results are posted, there are no reported p-values to interpret in light of multiplicity.

The primary outcome population is described as SDMs and PLWDs in all study arms who completed the baseline interview. This definition indicates that the reported outcome is based on baseline interview completers; it does not explain how participants without a baseline observation were handled. The record does not report the amount or pattern of missing data, reasons for missingness, imputation procedures, or sensitivity analyses. The endpoint entries include group counts, but the record does not provide participant flow information or reconcile those counts with the overall enrollment.

The intervention description mentions follow-up measures one week after baseline, but follow-up results for the primary measure are not posted. The control arm description is truncated after its reference to follow-up measures, so its full assessment schedule is not reported in the registry record. It is not possible to determine from the posted results whether all intended follow-up data were collected or how missing follow-up values were treated.

The analysis population is described only for the baseline endpoint. The record does not state whether analyses followed an intention-to-treat principle, used a per-protocol population, or applied another rule. The handling of participants according to their assigned groups, departures from assignment, and exclusions is not reported in the registry record. These details matter when interpreting a randomized study because they define which participants contribute to an analysis and how the assignment is represented.

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 serious adverse event counts for the control and intervention groups, alongside the numbers at risk. For serious adverse events, 0 affected participants are reported among 6 at risk in the control group and 0 among 8 at risk in the intervention group. The registry also reports 0 affected participants for other adverse events among 6 at risk in control and 8 at risk in intervention. Deaths are reported as 0 in both groups.

These figures describe what was recorded in the registry for the listed groups. They do not establish that no adverse events could occur, or that the groups have equal safety profiles. The number of participants at risk is limited, and an event not observed in a study can still be possible. The record does not provide details about how adverse events were solicited, defined, monitored, or attributed.

No serious adverse event terms are listed. The registry does not report additional narrative detail about safety events or a statistical comparison of adverse event rates. The counts should therefore be read as descriptive trial reporting, not as a definitive assessment of safety or as evidence that one group is safer than the other.

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

The posted results establish that the registry contains baseline confidence scores for PLWDs and SDMs in each assigned group, with means and full ranges on a scale from 1 to 5. They show that the reported scores vary by respondent role and group, and that the observed ranges are not identical across entries. The baseline summaries are a descriptive snapshot of confidence among participants who completed the baseline interview.

They do not establish that the website increased or decreased confidence. The primary outcome is reported at baseline, and no follow-up results or treatment-effect analysis for this scale are posted. The means should not be read as changes, causal effects, or evidence that the platform did or did not achieve the study's aims. They also do not establish usability or acceptability, despite those being stated aims of the pilot; results for those aims are not reported in the registry record.

The absence of a posted inferential comparison means the reader cannot assess the estimated size or statistical uncertainty of an intervention-versus-control effect on this outcome. The reported full ranges are not confidence intervals. The registry does not report a p-value, a confidence interval for a contrast, or a model-based estimate. The baseline group summaries alone cannot answer whether any observed difference is attributable to random variation, participant characteristics, or an intervention effect.

General statistical explanation: a pilot study can help establish whether procedures and measures are workable, but a pilot's descriptive results do not automatically answer an effectiveness question. The extent to which this study assessed feasibility is difficult to judge from the posted outcomes because usability and acceptability results are not included. The record also does not state how the enrollment was justified or how the pilot was intended to inform a later study.

The appropriate reading is narrow: these are small-group baseline summaries for an adapted confidence scale in the roles and groups listed. They are neither evidence of benefit nor evidence of no benefit. Additional follow-up results, a prespecified analysis, and sufficient information about missing observations would be needed to support a clearer assessment of change or between-group differences.

13. Why This Trial Matters Statistically

This trial is statistically notable because the stated intervention is an adaptation of an online advance care planning platform for people living with dementia and their shared decision-makers, while the posted primary measure focuses on decision-making confidence. Reporting the outcome separately for PLWDs and SDMs respects that the study addresses two perspectives. It also makes clear why a single pooled score could be difficult to interpret without a justified method for combining the roles.

The distinction between baseline description and intervention evaluation is central. The record reports baseline scores, while the intervention description places website review after baseline. Baseline summaries can characterize participants and provide context for later outcomes, but they do not show whether confidence changed. This is a useful example of why endpoint timing is as important as the endpoint's name when interpreting clinical trial results.

The study is described as a pilot, and its stated focus includes adaptation, usability, and acceptability. These aims are not interchangeable with demonstrating an effect on a clinical outcome. A pilot can be informative about whether an intervention and measurement approach warrant further evaluation, but the registry would need to report relevant feasibility results to support that interpretation. Those results are not reported in the registry record.

The posted information also illustrates the value of clear outcome reporting. Means and full ranges give some information about scores, but without a treatment contrast, uncertainty estimate, follow-up results, and missing-data description, readers cannot assess an intervention effect. In a randomized trial, these details help distinguish a descriptive snapshot from an analysis that directly answers a comparative question.

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 central limitation for interpretation is that the primary endpoint is recorded at baseline, while no follow-up score or change analysis for that endpoint is posted. The intervention description places website review after baseline. Consequently, the posted primary results do not evaluate whether the intervention altered decision-making confidence.

The study's stated aims include usability and acceptability, but outcomes addressing those aims are not reported in the registry record. The record lists six outcome measures, yet no secondary outcomes are posted. This limits the ability to judge whether the pilot's main feasibility objectives were met.

The enrollment is 14, and the primary endpoint entries are reported separately for role and group. The registry does not provide a participant flow account explaining the outcome counts, or state how the enrollment was selected. The precision of the group means is not quantified with standard deviations or confidence intervals. The full ranges show observed bounds but not the distribution of scores or uncertainty around a group estimate.

Important methodological details are also absent. The registry does not report a statistical analysis plan, a sample-size justification, missing-data procedures, or an analysis-population rule. It records double masking but does not identify who was masked or how masking was maintained. Randomization methods and allocation concealment are not described. The control-arm follow-up description is incomplete.

Finally, the adapted scale's measurement properties in this population are not reported in the registry record. The available summaries therefore cannot establish whether the measure performs consistently or has the same interpretation for PLWDs and SDMs. These limitations constrain interpretation of both the endpoint and the broader pilot aims; they do not, by themselves, establish that the study procedures were inadequate.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Our Care Wishes - Dementia — NCT05033262.
• Registry record last updated 2023-06-22; status last verified 2023-06.
• Results first posted 2023-06-22.
• 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

NCT05033262, titled Our Care Wishes - Dementia, is a completed randomized, parallel pilot with double masking recorded. The study adapted the OurCareWishes.Org advance care planning platform for persons living with dementia in nursing homes and their caregivers. Enrollment is 14, and the sponsor is the University of Pennsylvania.

The intervention, Our Memory Care Wishes, involved reviewing the website and entering advance care planning decisions and preferences. The control group received usual advance care planning care and nursing facility staff discussions without website review. The primary outcome is the Adapted Decision Making Confidence Scale at baseline, reported separately for PLWDs and SDMs.

The registry posts group means and full ranges but no formal comparison result for this endpoint. Follow-up results, missing-data methods, and a detailed statistical plan are not reported in the registry record. Serious adverse events, other adverse events, and deaths are reported as 0 affected in each group, with the group-specific numbers at risk stated in the safety results.