Building Resiliency in Patients Admitted to the Neuroscience Intensive Care Unit and Their Caregivers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Building Resiliency in Patients Admitted to the Neuroscience Intensive Care Unit and Their Caregivers (NCT03694678), a randomized na study. The primary outcome is Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads).

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group study with single masking. The registry does not identify who was masked, so the masking description alone does not establish whether participants, intervention staff, outcome assessors, or analysts were unaware of assignment. The study is listed as phase NA and completed. The registry reports an enrollment of 126. The study start date is 2019-01-01 and the primary completion date is 2020-10-01.

The randomized comparison was Recovering Together versus Health Education. Recovering Together was a behavioral intervention involving patient-caregiver dyads. The intervention description says that dyads were invited to 6 skills sessions lasting 30 minutes each, with both members included. Participants assigned to Recovering Together were also to receive usual clinic care as determined by their clinicians. Health Education was designed to mimic the intervention's dose and duration, without teaching the resiliency or interpersonal communication skills described for Recovering Together.

The dyad is central to the study question: the intervention was intended to involve patients and caregivers together, and the registry's feasibility outcome is framed around dyads. The record does not report the randomization procedure, allocation concealment, stratification, or the masking procedures. It also does not report the planned analysis model or explain how dependence between patient and caregiver observations would be handled.

The stated primary aim was to evaluate feasibility, credibility, and satisfaction with Recovering Together. A second aim was proof of concept for sustained improvement in emotional distress, post-traumatic stress, resiliency, and interpersonal communication outcomes. The registry record does not report results for these aims or specify the time points for the secondary outcomes.

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:

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: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.

6. Primary Endpoint

The registry lists the primary outcome as Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads), measured over Feasibility of program delivery will be measured at 6 weeks.

The primary outcome is titled “Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads).” Its population is described as the number of dyads who started Recovering Together and had at least one member complete a post-treatment assessment. The timeframe is 6 weeks. The registry also says that the number of sessions completed by each dyad and technical difficulties with live video delivery would be reported.

This kind of endpoint addresses whether an intervention can be delivered and whether participants engage with the assessment process. It is not, by itself, a measure of emotional distress or evidence that the intervention changes a clinical outcome. Counting dyads with at least one member completing an assessment captures one aspect of follow-up, while session completion and technical difficulties address delivery and implementation. These measures can help distinguish practical challenges from the intervention's hypothesized effects.

The record does not report the observed count of dyads meeting the assessment definition, the number of dyads who started Recovering Together, session-completion results, or technical difficulties. It therefore does not provide a feasibility estimate or enough information to assess the precision of such an estimate. The registry's outcome description defines what was intended to be measured; it does not supply the result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group comparison, but does not report the statistical analysis plan. The concepts below explain how such trial features are commonly interpreted; they do not describe unreported methods used in this study.

What does randomization contribute?

In general, random assignment is intended to make treatment groups comparable, on average, with respect to characteristics that could affect outcomes. It supports a causal comparison when assignment is maintained and outcomes are analyzed appropriately. Randomization does not guarantee identical groups, especially in a finite study, and it does not correct problems such as missing outcome data or departures from the intended analysis. The registry record does not describe how randomization was generated, concealed, or implemented.

What does the parallel-group design mean?

In a parallel design, participants are assigned to a group and assessed under that group assignment rather than crossing between interventions. The trial is described as parallel, but the registry does not provide the analysis model, the handling of adherence, or the definition of the population included in each analysis. Those details matter when interpreting a comparison because the result can depend on which participants and measurements are included.

Why does the dyad structure matter?

Recovering Together was delivered to patient-caregiver pairs, and the primary feasibility outcome is framed at the dyad level. The patients and caregivers within a dyad may have related experiences and outcomes. As a general statistical principle, observations from members of the same dyad may not be independent. Analyses of individual-level outcomes may need to account for that within-dyad relationship to avoid treating related observations as though they came from unrelated people. The registry record does not report whether or how such dependence was addressed.

The dyad-level feasibility measure has a different unit from patient-level or caregiver-level outcome measures. A count of dyads meeting an assessment criterion answers a practical delivery question. It should not be interpreted as an effect on emotional distress or another clinical outcome. The registry's description also mentions session completion and technical difficulties, which could provide further information about implementation, but their results are not reported in the registry record.

How should estimates and confidence intervals be understood?

In general, an effect estimate describes the observed contrast between groups for a defined outcome. A confidence interval expresses the statistical uncertainty around an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, but neither the estimate nor its interval establishes that an effect is clinically important. Interpretation also depends on the outcome definition, analysis population, missing-data handling, and whether the analysis was prespecified.

No treatment-effect estimates or confidence intervals for the listed outcomes are reported in the registry record. No recalculated estimates are available to interpret. Consequently, there is no basis for evaluating the magnitude or precision of a group difference.

Why can counts require careful interpretation?

The primary endpoint is a count of dyads meeting a stated assessment criterion. Counts become more interpretable when their denominator and observation period are clear. Without a denominator, a count alone cannot describe the proportion meeting the criterion. The registry identifies a 6-week timeframe, but the observed count and the denominator of dyads who started the intervention are not reported. A count of recorded events or assessments also depends on how those events or assessments were defined and collected.

What is over-dispersion, and is it relevant?

As a general concept, over-dispersion occurs when count data vary more than a statistical model assumes. A model that fails to account for extra variability can give uncertainty estimates that are too small. Whether over-dispersion matters depends on the outcome distribution and model. The registry record does not report a count model or enough outcome data to assess whether over-dispersion was present or relevant to the analysis.

What can planning illustrations establish?

Sample-size calculations are planning tools that describe the number of participants an assumed design might require to detect a chosen effect under stated conditions. They are not observed trial results and do not establish the power achieved by a completed study. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation, with the effect to detect defined as a fraction of an observed effect. The registry does not report an observed effect estimate for the outcomes at issue here, and the primary outcome is not reduced to one comparison. A planning illustration cannot fill that evidentiary gap.

More generally, a statistical test addresses compatibility between data and a specified null model under its assumptions. A p-value is not the probability that the null hypothesis is true, nor does it measure the size or importance of an effect. Since the registry record reports no analyses or test results, these concepts cannot be applied to claim statistical significance or a lack of it in this trial.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 9 outcome measures. The primary outcome concerns feasibility of intervention delivery, while the listed secondary measures include the Hospital Anxiety and Depression Scale, Post Traumatic Checklist, Measures of Coping Style Part A, Cognitive and Affective Mindfulness Scale Revised, and Dyadic Relationship Scale. The brief summary also describes emotional distress, post-traumatic stress, resiliency, and interpersonal communication as areas of proof-of-concept interest. The record does not report a hierarchy among secondary outcomes, a multiplicity adjustment, or a prespecified rule for interpreting several outcomes.

When several outcomes are tested, the chance of finding at least one apparently unusual result can increase if each test is interpreted separately. As a general principle, prespecified outcome priorities and methods for handling multiple comparisons help readers distinguish confirmatory results from exploratory ones. The registry record does not report whether such procedures were planned or used. It lists 0 analyses, so no outcome-specific estimates or tests are available for interpretation.

Missing-data handling is not reported in the registry record. The primary outcome's definition depends on post-treatment assessment, but the record does not give the number of missing assessments, reasons for missingness, or methods for handling missing observations. It also does not report whether all randomized participants were included in analyses, how adherence was considered, or which analysis populations were used. These omissions prevent assessment of attrition and of how analysis choices might affect results.

Interim analyses and stopping rules are not reported in the registry record. The completed status does not establish what monitoring or analysis procedures were used.

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 four groups: Recovering Together patients, Recovering Together caregivers, Health Education patients, and Health Education caregivers. The serious adverse-event count is 0 in each group; the other adverse-event count is also 0 in each group. The deaths count is 0 for each group. The associated at-risk counts are 30 for each Recovering Together group and 31 for each Health Education group.

These entries describe what is recorded in the registry, not a comparative safety analysis. The record does not report an event-ascertainment period, definitions of serious and other adverse events, or additional details about how events were collected. It also does not provide estimates with uncertainty. The zero entries should therefore be read as registry counts rather than interpreted as proof that no events occurred under any definition or outside the recorded reporting process.

Patient and caregiver groups are listed separately. The numbers should not be added together to create an overall participant count, and the entries should not be treated as a rate without a defined observation period and analysis. The safety information does not address whether Recovering Together affected the clinical outcomes named in the study aims.

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

The registry record describes a randomized comparison intended to evaluate Recovering Together against Health Education in patient-caregiver dyads. Its primary focus is feasibility, credibility, and satisfaction, with proof-of-concept aims involving emotional distress, post-traumatic stress, resiliency, and interpersonal communication. These are study aims, not reported findings.

The primary endpoint definition identifies a practical measure: dyads who began Recovering Together and had at least one member complete a post-treatment assessment. The record also says session completion and technical difficulties with live video delivery would be reported. It does not give the observed feasibility count, its denominator, or those implementation results. Thus, the registry information does not show how successfully the intervention was delivered.

The record does not provide estimates comparing Recovering Together with Health Education on the listed secondary outcomes. It therefore cannot establish the direction or size of any difference, how precise an estimate might be, or whether any difference would be meaningful. The absence of reported analyses is not evidence of no effect; it means the registry record does not report the analyses needed to evaluate effects.

The recorded adverse-event entries show zero serious events, zero other events, and zero deaths for each listed patient and caregiver group. These counts should be read in the context of the registry's limited event detail. They do not establish a comprehensive safety comparison, and they do not answer the trial's questions about feasibility or emotional outcomes.

The trial's completed status and enrollment entry provide context about the registered study, but they do not supply outcome evidence. A reader can identify what the trial set out to compare and what its primary outcome was intended to measure. The registry record does not support a conclusion about whether Recovering Together changed the outcomes of interest.

13. Why This Trial Matters Statistically

This trial is statistically notable for framing an intervention around patient-caregiver dyads rather than patients alone. Recovering Together was designed for both members of a dyad, and its primary feasibility outcome is also defined at the dyad level. That alignment between intervention unit and feasibility unit makes clear what kind of delivery question the primary endpoint was intended to address.

The study also illustrates why feasibility and clinical outcomes need distinct interpretations. A measure of whether dyads completed an assessment or sessions can inform whether an intervention can be delivered and evaluated. It does not, on its own, estimate changes in emotional distress, post-traumatic stress, resiliency, or communication. Keeping those questions separate helps avoid treating engagement measures as evidence of clinical effect.

Dyadic studies also raise an important general modeling issue: outcomes from a patient and caregiver in the same pair may be related. Statistical analyses should reflect the structure of the data when that dependence is relevant. The registry record does not report the model or how the relationship between members of a dyad was handled, so readers cannot evaluate that aspect of the analysis.

Finally, the registry record makes the distinction between a registered objective and a reported result especially important. Although the study is marked completed and lists outcome measures, it reports 0 analyses. Without estimates and uncertainty measures, readers cannot assess the strength or precision of evidence for the stated aims. Transparent outcome reporting is necessary for interpretation, replication, and planning of later research.

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 main limitation for interpretation is that the registry record does not report outcome analyses. It lists 0 analyses, so there are no reported estimates or uncertainty intervals for the primary feasibility outcome or the clinical outcomes described in the study aims. The record also does not give the primary feasibility numerator or denominator, session-completion results, or reported technical difficulties.

The registry identifies 9 outcome measures but does not report a complete analysis plan, an outcome hierarchy beyond the designation of a primary outcome, or methods for addressing multiple comparisons. Missing-data methods, analysis populations, and the handling of adherence are also not reported in the registry record. Without these details, readers cannot assess attrition, the influence of analysis choices, or how the results would relate to all randomized participants.

Details of the randomization procedure and the target of single masking are not reported in the registry record. Nor does it report how analyses accounted for the relationship between patients and caregivers within dyads. These omissions limit assessment of possible bias and of whether the statistical methods matched the study structure.

The record lists the study dates and enrollment but does not provide further participant characteristics or a detailed account of the assessment schedule for secondary outcomes. It does not specify the event-ascertainment period or detailed definitions for the adverse-event entries. The listed counts therefore have limited context.

These are limitations of what the registry record reports; they do not establish that particular methods were absent from the study. They mean those methods and results are not available in the record for statistical evaluation.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Building Resiliency in Patients Admitted to the Neuroscience Intensive Care Unit and Their Caregivers — NCT03694678.
• Registry record last updated 2025-05-28; status last verified 2025-05.
• Results first posted 2025-05-28.
• 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

The registry identifies NCT03694678 as a completed, randomized, single-masked, parallel-group study of Recovering Together versus Health Education for patients with acute neurological illnesses and their caregivers. The listed condition is acute brain injuries. Enrollment is 126; the study start date is 2019-01-01 and the primary completion date is 2020-10-01. The phase is listed as NA.

The primary outcome concerns feasibility of delivering the intervention to dyads, including a post-treatment assessment criterion at 6 weeks. The study also aimed to examine emotional distress, post-traumatic stress, resiliency, and interpersonal communication. The registry lists 9 outcome measures and 0 analyses. Outcome estimates and primary feasibility results are not reported in the registry record.

Adverse-event entries list zero serious events, zero other events, and zero deaths in each of the four patient and caregiver groups. The record does not provide further event-ascertainment details.