Care to Plan: a Tailored Resource for Family Members of Persons With Dementia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Care to Plan: a Tailored Resource for Family Members of Persons With Dementia (NCT03901456), a randomized na study. The primary outcome is Caregiver Self-efficacy.

2. Clinical Question

3. Trial Design

The record describes a completed, randomized, single-masked, parallel study sponsored by the University of Minnesota. Its registered title is “Care to Plan: a Tailored Resource for Family Members of Persons With Dementia.” The overall enrollment is listed as 65. The study start date is 2019-09-01, and primary completion is listed as 2022-05-24. The phase is recorded as NA.

The project includes a non-randomized Phase I treatment arm as well as randomized Phase II treatment and control arms. Phase I participants received the intervention without a comparison group. Phase II participants were randomized to Care to Plan or usual care. The primary caregiver self-efficacy outcome is explicitly restricted to Phase II. Phase I therefore should not be combined with the randomized arms when interpreting a treatment comparison.

Care to Plan is a behavioral intervention described as an online resource. The comparator is also categorized as behavioral and is described as usual care. The record states that control participants who were eligible could be asked whether they were interested in enrolling in a similar additional feature after the initial 6-month study. It does not establish that every control participant received this feature.

The registry identifies the study as single-masked but does not report which participants, staff, or assessors were masked, or how masking was maintained. The randomization method, allocation concealment, site structure, and details of usual care are not reported in the registry record. No further protocol information about intervention delivery or adherence is 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: Sixty-five participants consented to participate (during Phase I or Phase II of the project). Two participants did withdrew or were lost to follow up prior to initial survey completion. Data is reported for 63 participants completing the initial survey.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Outcome reported for Phase II only; number analyzed varies by treatment arm and timepoint (due to missing data and/or withdrawal).

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 Caregiver Self-efficacy, measured over Phase II Baseline, 3-months, 6-months.

The primary outcome is caregiver self-efficacy, defined as the mean of participant scores on an 8-item survey developed by Fortinsky and colleagues. Each item is scored from 1 (Very unconfident) to 5 (Very confident), and the 8 item responses are averaged. Higher scores indicate greater self-efficacy. The registry describes the outcome unit as scores on a scale and reports the mean of participant scores.

Self-efficacy captures caregivers’ reported confidence in their ability to manage relevant caregiving demands. As a caregiver-reported measure, it represents a subjective assessment rather than a direct count of services used, caregiving tasks completed, or clinical events. A change in this score would describe a change in reported confidence; by itself, it would not establish changes in other aspects of caregiving or in the health of the person receiving care.

The endpoint is scheduled at Phase II baseline, 3-months, and 6-months. The registry notes that the number analyzed varies by arm and timepoint because of missing data and/or withdrawal. It does not report the observed mean scores, standard deviations, changes from baseline, or between-arm contrasts at any assessment. Consequently, the outcome definition is available, but the recorded results do not allow the size or precision of an effect on self-efficacy to be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, single-masked, parallel Phase II comparison of Care to Plan with usual care. General statistical explanation can clarify what such a comparison is intended to estimate, but the registry record does not report the analysis used for the primary outcome. The methods below therefore distinguish standard concepts from trial-specific analysis details that are unavailable.

What does randomization contribute?

In general, random assignment is intended to make treatment groups comparable, on average, with respect to measured and unmeasured characteristics at assignment. This supports interpreting a between-group contrast as an estimate of the effect of assignment to the intervention, subject to issues such as missing outcome data and departures from the intended conduct. The record confirms randomization in Phase II, but does not report the sequence-generation method, allocation concealment, or a baseline comparison. It also does not identify the exact analysis population or state whether the primary analysis followed assignment regardless of tool use.

The non-randomized Phase I treatment group has a different role. Without a concurrent randomized comparison, outcomes from that phase cannot be treated as an equivalent control contrast for Phase II. The primary self-efficacy outcome is reported for Phase II only, and the record’s Phase I arm is identified as non-randomized.

How should a continuous outcome be understood?

Caregiver self-efficacy is a continuous scale score. For a continuous outcome, an arm mean describes the average score among participants included in that calculation. A mean difference would describe the separation between arm averages on the scale, with its sign depending on the order of subtraction. Standard deviations describe how spread out participant scores are around an arm mean; they are not the same as uncertainty in the estimated mean.

A confidence interval, in general, expresses the range of effect estimates compatible with the observed data under the statistical model and its assumptions. A narrower interval indicates greater precision, while a wider interval indicates less precision. A confidence interval is not a guarantee that the true effect lies within its limits. The registry record does not report a confidence interval or an estimated between-arm difference for self-efficacy, so neither the effect’s precision nor its scale-level magnitude can be assessed.

Why do repeated assessments require an analysis choice?

The outcome is scheduled at baseline, 3-months, and 6-months. Repeated measurements on the same participant are related rather than independent. General methods for repeated measures account for this within-participant association, and different methods can target different quantities, such as a difference at a particular follow-up time or an average pattern across follow-up. The registry record does not report which approach was used, whether baseline scores were included as a covariate, or what contrast was designated as primary for inference.

The outcome description states that the number analyzed varies by arm and timepoint because of missing data and/or withdrawal. This means the available observations may differ across assessments. General repeated-measures methods can make assumptions about how missingness relates to observed and unobserved outcomes. The record does not report the amount or pattern of missingness, the reasons for missing observations, or the method used to handle them. No assumption about those choices can be made from the stated endpoint description alone.

What can the planning assumptions tell readers?

The registry describes sample-size illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated target effect is a fraction of the observed effect. These are planning assumptions, not a report of the trial’s original design rationale. The record does not report a sample-size justification for the trial, and numerical planning outputs are not reported in the registry record.

In general, planning illustrations ask how many participants per arm might be required under specified assumptions to detect a chosen effect with a chosen power. Such calculations depend on the effect size and variability assumptions. They are not observed power and do not establish what the study was capable of detecting after it was conducted. If the observed effect used as a planning reference is uncertain, the resulting illustration is uncertain as well. The registry record does not describe whether these assumptions were used in planning the trial.

What is not documented?

The registry reports zero analyses and does not provide the primary outcome estimates. A prespecified statistical analysis plan, model specification, handling of multiple comparisons, and analysis population are not reported in the registry record. General statistical principles can explain why these details matter, but cannot identify which procedures were used in this study. The record also does not report interim analyses or stopping rules.

10. Multiplicity, Missing Data and Analysis Populations

The primary self-efficacy measure is scheduled at baseline, 3-months, and 6-months. If separate inferential tests are performed at multiple times, or across multiple outcomes, the chance of at least one false-positive finding can increase. General approaches to multiplicity include defining a primary contrast in advance, adjusting inference across a family of tests, or treating secondary analyses as exploratory. The registry record does not report whether an adjustment was planned or used, or which timepoint or contrast was the principal inferential comparison.

The record lists seven outcome measures. Named secondary outcomes include Care to Plan service use, caregiver distress: role overload, loss of intimate exchange, caregiver distress: role captivity, and CES-D. This range of outcomes raises an interpretive issue: without a prespecified hierarchy or stated multiplicity strategy, individual findings could be difficult to distinguish as confirmatory or exploratory. A hierarchy or adjustment plan is not reported in the registry record.

Missingness is explicitly relevant to the primary endpoint: the number analyzed varies by arm and timepoint because of missing data and/or withdrawal. The record does not report how many scores are missing, whether missingness differs between arms, reasons for missingness, or whether participants who withdrew differed from those who remained. It also does not state whether analyses used available observations, imputed values, or another approach. These details are not reported in the registry record.

In general, missing-data methods rely on assumptions about why values are absent. If missingness is related to observed information, an analysis may be able to use that information; if it depends on unobserved outcomes, additional assumptions or sensitivity analyses may be important. These are general considerations, not claims about what occurred in this study.

The primary population is described as Phase II only, but the exact analysis population and any exclusions are not reported in the registry record. As a result, the effect of missingness, analysis-set decisions, and multiplicity cannot be evaluated from the registered outcome information.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: uti (4.5%).

The serious-event figures are reported separately for Phase II treatment, Phase II control, and non-randomized Phase I treatment. For serious adverse events, the record lists 1 participant affected among 22 at risk in the Phase II treatment arm, 0 among 21 at risk in Phase II control, and 0 among 20 at risk in Phase I treatment. Deaths are listed as 0 in each group.

For other adverse events, the corresponding figures are 7 among 22 at risk in Phase II treatment, 4 among 21 at risk in Phase II control, and 0 among 20 at risk in Phase I treatment. UTI is listed as a top serious term at 4.5%. These are reported counts and a listed term; the registry does not provide further detail in this record about event timing, severity grading, recurrence, or attribution to the intervention.

Counts alone do not establish that a treatment caused an event, and descriptive counts are not a formal comparison of safety between randomized groups. The Phase I arm was not randomized and should not be treated as a randomized safety comparator. The registry record does not report a statistical safety analysis or the criteria used to classify events. The figures therefore describe events recorded in each group, not a causal estimate of risk.

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

The record establishes that the study evaluated Care to Plan in a project involving family members of persons with dementia and that Phase II used random assignment to compare the tool with usual care. It also defines a caregiver self-efficacy endpoint and reports that the number analyzed varies by treatment arm and timepoint because of missing data and/or withdrawal. These registry entries help readers understand the research question and the outcome being targeted.

What the record does not establish is the size or direction of the primary outcome result. No self-efficacy scores or treatment contrasts are reported. It is therefore not possible to say from these registry results whether average scores differed, how precise any difference was, or whether changes were sustained across the scheduled assessments. The absence of those estimates should not be interpreted as evidence that the groups were identical, nor as evidence that a difference existed.

The study’s preliminary-efficacy framing describes its purpose, not a result. Likewise, a measure’s definition and a study’s completed status do not show that an intervention changed the measure. Interpretation requires outcome estimates, uncertainty measures, and enough analysis detail to understand how missing observations and repeated measurements were handled. Those elements are not reported in the registry record.

The adverse-event counts provide a separate descriptive account. They do not answer the self-efficacy question, and they do not by themselves establish that an event was caused by the intervention or that the groups had different safety profiles. The non-randomized Phase I arm also cannot serve as a randomized comparator.

Accordingly, the record is informative about the design and measurement strategy but insufficient for a quantitative conclusion about preliminary efficacy. It does not support medical advice or a conclusion about how the resource should be used. Further interpretation would require reported outcome analyses and relevant details of the statistical methods.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it evaluates a tailored resource against usual care while focusing on a caregiver-reported outcome. Caregiver self-efficacy is measured using an 8-item scale, with higher scores defined as greater confidence. That makes the result interpretable as a report of caregivers’ own confidence, rather than as a direct measure of service use or clinical events.

The design also contains distinct phases that need to be kept separate. Phase I was non-randomized and had no comparison group; Phase II was randomized. The primary outcome is reported for Phase II only. Treating the phases as interchangeable would blur the difference between a preliminary intervention experience and a randomized comparison. The registry identifies this distinction, which is essential when considering what evidence a group contrast could provide.

Repeated assessment at baseline, 3-months, and 6-months creates a need to specify how observations over time are analyzed. Missing data and/or withdrawal mean the number analyzed varies by arm and timepoint, making the handling of incomplete follow-up particularly relevant. The registry record does not report the analysis method or the outcome estimates, so readers cannot assess how these statistical issues affected the results.

The record is therefore a useful example of why trial registration and outcome reporting serve different purposes. Registration identifies the planned question and measures; a meaningful statistical interpretation also requires estimates, uncertainty, and transparent analysis details. Here, the design and endpoint are described, but the numerical primary outcome results are not reported in the registry record.

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 statistical interpretation is that the registry record does not report the primary self-efficacy results. No arm-level means, standard deviations, estimated contrasts, confidence intervals, or p-values are available. This prevents assessment of effect magnitude, direction, and precision, despite the endpoint being clearly defined.

Although overall enrollment is listed as 65, the record does not state how many participants were randomized in Phase II or provide the number analyzed at each arm and timepoint. It notes that analyzed numbers vary because of missing data and/or withdrawal, but does not describe their extent or reasons. This leaves uncertainty about the completeness and comparability of the repeated outcome data.

The study includes both a non-randomized Phase I treatment group and randomized Phase II groups. Phase I has no comparison group and is not part of the primary Phase II outcome population. Any interpretation that combines these groups would need justification that is not reported in the registry record.

Other trial-specific details relevant to bias and inference are also not reported: the randomization procedure, allocation concealment, which party was masked, the content of usual care, and the statistical model. The record does not state how multiplicity across assessment times and outcomes was addressed, or how the analysis population was defined. These omissions limit the ability to evaluate the methods independently of the missing results.

The posted adverse-event counts lack reported attribution and a formal comparison. The registry also does not provide outcome results for the listed secondary measures in this record. These limitations restrict both efficacy and safety interpretation to the information explicitly recorded.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Care to Plan: a Tailored Resource for Family Members of Persons With Dementia — NCT03901456.
• Registry record last updated 2023-06-02; status last verified 2023-06.
• Results first posted 2023-06-02.
• 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

NCT03901456 is a completed, randomized, single-masked, parallel study sponsored by the University of Minnesota. Its overall enrollment is listed as 65. The study record includes non-randomized Phase I treatment and randomized Phase II treatment and control groups. The primary outcome is caregiver self-efficacy in Phase II, measured with an 8-item scale at baseline, 3-months, and 6-months.

Care to Plan is described as an online care-planning resource that generates individualized caregiver recommendations and links. The randomized comparator is usual care. The record notes variation in the number analyzed by arm and timepoint due to missing data and/or withdrawal. It does not report primary outcome scores or a statistical comparison of the randomized groups. Serious and other adverse-event counts are listed by group, but the record does not report a formal safety analysis or event attribution.