CONFIDENCE-AI Financial Education for Caregivers (CONFIDENCE-AI): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for CONFIDENCE-AI Financial Education for Caregivers (CONFIDENCE-AI) (NCT06134180), a na na study. The primary outcome is Financial Strain.

2. Clinical Question

3. Trial Design

CONFIDENCE-AI is registered as a completed, single-group behavioral study sponsored by Case Western Reserve University. The registry lists the study start as 2024-03-23 and primary completion as 2025-04-01. Enrollment was 14. The phase and allocation are listed as NA, and masking is listed as none. The record does not identify a randomized comparator, consistent with its single-group model.

The intervention is described as a 4-week program. Participants attend four group-based videoconference sessions, each approximately 1.5 hours, and complete activities between sessions to apply what they learn. They also receive tailored text notifications from the NeuViCare AI-powered app and may submit questions to it about financial well-being in caregiving. The intervention description mentions financial topics, including budgeting and accessing community resources, though the full arm description is not available in the registry record.

The primary outcome is financial strain. The stated timeframe describes average change from baseline to a post-intervention collection point at 1 month post-baseline and to a later point described as 2 months post-intervention, 3-months after the baseline. These are within-participant time comparisons; the record does not define a control condition or an adjusted between-group contrast.

The record lists Self-Efficacy as a secondary outcome and reports three outcome measures overall. Details for every outcome measure are not reported in the registry record. It lists zero analyses, and numerical outcome results, analysis methods, and estimates of uncertainty are not reported. Consequently, the completed status and intervention description should not be mistaken for a posted assessment of 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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: From baseline to the post-intervention data collection point, three participants were lost to follow up and one participant was missing a survey item response required to calculate this score. Thus, data is available for 10 of 14 participants. From baseline to the 2-month post-intervention data collection point, one more case was lost to follow up and another was missing a survey item response required to calculate this score. Thus, data is available for 9 of 14 participants.

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 Financial Strain, measured over The outcome measure will use the average change score from baseline scores until post-intervention (1 month post-baseline) and 2 months post-intervention (3-months after the baseline)..

Financial strain is the primary endpoint. It is measured with the 11-item Comprehensive Score for Financial Toxicity Scale, described as a measure of financial toxicity. The registry notes that a modified version has demonstrated validity and reliability among cancer caregivers, with α=0.91 and a range of 0 to 44. It also states that the items are generic enough to apply to caregivers of persons PLWD without further modification. Respondents indicate how much each statement applies, from Not at all to Very much. Higher scores indicate higher financial strain.

The endpoint is relevant to the intervention's stated focus on psychological financial strain and management of out-of-pocket care costs. A repeated score can describe how financial strain changes over time within the study group. The registry specifies an average change score from baseline to post-intervention and a later follow-up, but does not report the observed score changes, the score distributions, or the way change is signed. The outcome values and their precision are therefore not reported in the registry record.

The scale's stated range gives context for what the instrument measures, but it does not establish how much change would matter to caregivers. A threshold for meaningful change is not reported in the registry record. Nor is a clinical interpretation or minimal important difference stated. The endpoint can be described as a self-reported measure of financial strain; conclusions about the size or importance of any change require results and interpretive criteria that are not reported.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is continuous: it is a score on a scale, and the registry identifies the summary as a mean with standard deviation. These summaries have distinct roles. A mean describes the average score or average change in the analyzed group. A standard deviation describes how dispersed individual scores are around that mean. Neither quantity is reported for the primary endpoint in the registry record.

What does a change score represent?

In general, a change score compares a participant's measurement at a later time with that participant's measurement at baseline. Averaging those participant-level changes describes the average within-person change among participants whose data contribute. The registry calls for an average change score from baseline to the post-intervention collection point and to a later collection point. It does not state whether a positive change means higher or lower strain, so the direction convention is not reported in the registry record. The average changes and their standard deviations are also not reported.

Repeated measurements can help describe how scores vary over time, but their interpretation depends on which measurements are available and how the analysis accounts for their relationship within participants. As a general statistical point, measurements from the same person are usually related rather than independent. An analysis that ignores this dependence can misstate uncertainty. The analysis method used for this study is not reported in the registry record, and the record lists zero analyses.

How should uncertainty be understood?

As a general statistical explanation, a confidence interval is a range of values compatible with an estimate under the method's assumptions. It communicates precision: a narrower interval indicates less uncertainty about the estimate than a wider interval. A p-value addresses how compatible the observed data are with a specified null model; it does not measure the size or practical importance of a change. The registry record reports no confidence interval or p-value for financial strain, and the null hypothesis and inferential procedure are not reported.

The single-group design is central to interpretation. A before-and-after estimate can describe change in the observed group, but there is no concurrent control-group contrast in this record. As a general statistical point, an uncontrolled change cannot distinguish an intervention effect from time-related change, external events, or other influences. Statistical adjustment cannot create a randomized control group when none is part of the design. The registry does not report a causal analysis or adjustment plan.

Why can missing observations matter?

The registry reports that, between baseline and the post-intervention collection point, three participants were lost to follow up and one participant had a missing survey item needed to calculate the score. It says data were available for 10 of 14 participants for that period. A mean calculated from available outcomes describes those observed participants. If the reasons for missingness are associated with financial strain or with change in strain, that mean may not describe the whole enrolled group. This is a general concern, not a claim that bias occurred in this study. The record does not report imputation, a sensitivity analysis, or assumptions about missingness. Details about data availability for the later time point are not reported in the registry record.

What does the planning framework say?

The registry's planning assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. The effect to detect is specified as a fraction of the observed effect. These assumptions do not describe the single-group design itself, which has no two-arm allocation. No numerical planning outputs or observed effect are reported in the registry record. A planning illustration is not observed power, and it cannot supply missing outcome findings. The registry record does not report the trial's own sample-size justification or whether this illustration was used in planning.

As a general matter, a planning calculation depends on its assumed effect size, variability, allocation, and statistical test. If the assumed effect is based on an observed estimate, uncertainty in that estimate also matters. A planning target does not guarantee that a future study will detect an effect, and it does not describe the information actually obtained in this completed study. The sample-size assumptions stated in the record should therefore be read as a planning framework, not as evidence about the financial-strain result.

How does multiplicity affect interpretation?

The registry lists three outcome measures and identifies Self-Efficacy as a secondary outcome. When several outcomes or time contrasts are tested, the chance of at least one nominally unusual result can increase if no adjustment or prespecified hierarchy is used. This is a general statistical issue. A multiplicity strategy, the intended hierarchy among outcomes, and analyses for the listed outcomes are not reported in the registry record. With no reported estimates or tests, there is no basis to evaluate whether multiplicity changed the interpretation of results.

The record also notes a modified scale's reported reliability and validity in cancer caregivers. Those properties provide background about the measure, not evidence that the intervention changed scores in this study. Nor do they replace reporting of the study's endpoint estimates, variability, missing-data handling, and inferential method. Those elements are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and identifies Self-Efficacy as a secondary outcome. It does not identify every outcome measure in the available record, state a hierarchy for testing outcomes, or describe an adjustment for multiple comparisons. The number of analyses listed is zero. Thus, the registry record does not provide a statistical testing plan or results from which to assess multiplicity. As a general point, considering several outcomes or time contrasts can increase the chance of a nominally significant result occurring by chance if testing is not accounted for. Whether that issue arose in this study is not reported in the registry record.

For financial strain from baseline to the post-intervention collection point, three participants were lost to follow up and one participant was missing a survey-item response required to calculate the score. The record states that data were available for 10 of 14 participants for this comparison. These are distinct reasons for unavailable outcome data, and the record does not state how the analysis handled them. Imputation, sensitivity analyses, and assumptions about missingness are not reported in the registry record.

The available description of data availability for the later collection point is incomplete, so its missing-data count and analyzed population are not reported in the registry record. A definition of the analysis population, including whether all enrolled participants or only those with observed scores were included, is also not reported. These omissions make it impossible to assess how representative the analyzed scores were of the enrolled group or how robust any estimate might be to missing data.

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 lists 14 participants at risk in the CONFIDENCE-AI group. It records zero serious adverse events, zero other adverse events, and zero deaths. No serious adverse-event terms are listed. These entries describe what is recorded in the registry for the study; they do not establish that no unrecorded or unrecognized events occurred.

As a general statistical point, a zero event count in a study group is not proof that the underlying risk is zero. The count is observed within the study's recorded follow-up and reporting context. The registry record does not describe the adverse-event collection method, the observation window, event definitions, or the detail of safety surveillance. It also does not provide event-level descriptions beyond the absence of listed serious terms.

Because this is a single-group study, the safety figures do not provide a comparative estimate against another intervention or a control group. The entries should be read as registry-reported counts, not as a demonstration of comparative safety. Additional context about how events were solicited and reviewed is not reported in the registry record.

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

The registry record describes a completed, single-group study of CONFIDENCE-AI and identifies financial strain as its primary outcome. It explains that the outcome uses an 11-item scale and specifies assessment from baseline to post-intervention and a later follow-up. It also reports that, for baseline to post-intervention, outcome data were available for 10 of 14 participants after losses to follow up and a missing survey item.

What the record does not provide is the numerical result needed to determine whether scores changed, in which direction, or by how much. Mean change, standard deviation, confidence interval, and p-value are not reported in the registry record. The scale's range and description do not substitute for those results. A reader therefore cannot judge the size or precision of any change from the registry information.

Even if a within-group change were available, the design would not establish that CONFIDENCE-AI caused that change. The study has no randomized comparator identified in the registry record. Changes over time can coincide with the intervention without being attributable to it, and an uncontrolled design cannot separate those explanations. The record also does not state a threshold for a change that would be meaningful to caregivers.

The listed safety counts report zero serious adverse events, zero other adverse events, and zero deaths among the recorded group. Those counts do not establish zero underlying risk or comparative safety. The record does not describe the safety observation procedures in enough detail to assess how events were ascertained.

Accordingly, the available registry information supports a description of the intervention, planned outcome, design, and some missing-data and safety counts. It does not support a conclusion about whether financial strain improved or worsened, the size or importance of any change, or a causal effect of the intervention. The outcome analyses and their estimates are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial raises statistical questions that matter for interpreting caregiver interventions. The primary endpoint is a self-reported financial-strain score, and the stated objective includes psychological financial strain and management of out-of-pocket care costs. Repeated measurement is suited to describing how scores change over time, but the value of that description depends on transparent reporting of estimates, variability, uncertainty, and who contributed data.

The single-group design makes the distinction between observed change and intervention effect especially important. Without a concurrent comparator, a before-and-after pattern cannot by itself separate the intervention from other events or changes over time. This is not a question that can be resolved by a p-value alone. A precise estimate of within-group change would still not provide the missing control-group contrast.

Missing outcome data are also consequential in a small enrolled group. The registry reports unavailable data for the baseline-to-post-intervention comparison and does not describe the missing-data method. In general, outcome availability can affect both precision and representativeness, particularly when missingness is related to participants' circumstances or outcomes. Reporting the pattern of missingness and sensitivity to plausible assumptions is therefore important.

The record further lists multiple outcome measures without reporting the analysis plan or results. Clear specification of outcome hierarchy and multiplicity handling helps readers distinguish primary from exploratory findings. Here, those details are not reported in the registry record. The record's completion status, intervention description, and planning assumptions do not fill that gap. The statistical importance of this study lies in these design and reporting questions as much as in its intended measure of financial strain.

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 primary limitation for interpreting outcomes is that numerical results are not reported in the registry record. No mean change, standard deviation, confidence interval, or p-value is given for financial strain. The record lists zero analyses. Consequently, the magnitude, direction, and precision of the primary outcome cannot be assessed.

The single-group design has no randomized comparator identified in the record. Any change over time would not by itself distinguish the intervention from other influences. The registry also does not report an analysis plan, a causal estimation strategy, or a threshold for meaningful change. Allocation is listed as NA, and masking as none.

Outcome availability is incomplete for the baseline-to-post-intervention comparison: three participants were lost to follow up and one participant lacked a required item response, with data available for 10 of 14 participants. The later follow-up's data availability is not reported in the registry record. Nor are the missing-data method, analysis population, imputation approach, or sensitivity analyses described.

The registry lists three outcome measures but names only Self-Efficacy as a secondary outcome in the available information. The complete outcome set, multiplicity strategy, and results for secondary measures are not reported in the registry record. The record's sample-size assumptions describe a planning illustration rather than a reported trial analysis; numerical planning outputs and the trial's own sample-size justification are not reported.

The scale description includes reliability and validity context from cancer caregivers, but the record does not provide the study's own measurement-performance results or a meaningful-change threshold. Safety counts are reported without details of event ascertainment or observation procedures. These limitations restrict both the interpretation of outcomes and the assessment of how broadly the findings might apply.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: CONFIDENCE-AI Financial Education for Caregivers (CONFIDENCE-AI) — NCT06134180.
• Registry record last updated 2025-07-30; status last verified 2025-07.
• Results first posted 2025-07-30.
• 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

CONFIDENCE-AI is a completed, single-group behavioral study sponsored by Case Western Reserve University. The registry lists enrollment of 14 and describes a 4-week program with four videoconference group sessions, between-session activities, and text-based support through an AI-powered app.

Financial strain, measured with the Comprehensive Score for Financial Toxicity Scale, is the primary outcome. The record describes repeated assessment but does not report numerical outcome results or analyses. For baseline to post-intervention, data were available for 10 of 14 participants after three losses to follow up and one missing survey item. Later follow-up data availability is not reported in the registry record.

The registry lists zero serious adverse events, zero other adverse events, and zero deaths. The study has no randomized control group identified in the record, and the available information does not establish a causal effect or provide a comparative safety estimate.