Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth (NCT05120843), a na na study. The primary outcome is Reasons for Non-participation (Acceptability).

2. Clinical Question

3. Trial Design

NCT05120843 is recorded as a single-group, open behavioral study of care coordination and motivational interviewing for women with a recent preterm birth. The intervention combined care coordination with motivational interviewing strategies. The study description characterizes it as a small trial to test implementation and refine the intervention before ongoing feasibility testing. It was not designed as a randomized comparison: allocation is recorded as not applicable, and there is no like-for-like control arm.

The registry records enrollment of 13 participants and lists the study status as terminated. The recorded study start date is 2022-02-03, and the primary completion date is 2023-09-23. The reason for termination is not reported in the registry record. Phase is recorded as not applicable. Masking is recorded as none, consistent with the open design.

The primary outcome concerns reasons for non-participation among women who decline enrollment, including possible study changes that might have encouraged participation. Other listed outcomes concern autonomy support, autonomous motivation, preventive care visits, and recommended care completion. The registry lists 11 outcome measures overall, but it does not report analysis entries. A planned sample size, justification for enrollment, detailed intervention schedule, and statistical analysis plan are not reported in the registry record.

These design features define what can be learned from the record. The study can be described as a feasibility and acceptability effort, but its single-group structure does not support a direct treatment-versus-control estimate. The recorded enrollment also does not establish how many people were screened, how many declined, or how many contributed information to any particular 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: We have included a Table for the screening and enrollment phase of the study because a major goal of the study was to assess feasibility of screening and enrollment procedures, as well as reasons for non-participation. This table, and the numbers included in this table, support calculation of Outcomes 1 - 3. In addition they provide important information about feasibility that are relevant to other research in this area.

Screening and Enrollment Phase

Reasons for not completing this period:

Intervention Phase

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: See Participant Flow Section. The screening rate was 100% in that we were able to review all potentially eligible participants as defined here.

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 Reasons for Non-participation (Acceptability), measured over Screening phase (Up to 1 week prior to enrollment).

The primary outcome is the number of people giving reasons for non-participation. During the screening phase, described as up to 1 week before enrollment, women who decline enrollment were to be asked, if willing, why they chose not to participate and what changes might have encouraged participation. Responses were intended to be tabulated and reviewed for potential themes. The population description points to the participant flow information, but the number approached or declining is not reported in the registry record.

This kind of outcome addresses acceptability and the practical process of recruitment. Reasons for declining can identify perceived obstacles or possible changes to study procedures, helping investigators consider how to refine an intervention study. The measure is not a clinical efficacy endpoint: it does not quantify a treatment effect on health, care use, or behavior. The registry record does not report the resulting count, the responses, or any themes identified.

General: A count outcome records how many people or events meet a definition. Its meaning depends on a clear denominator and a consistent process for identifying and recording each item. For a voluntary response question, the count of responses is not necessarily the same as the count of people who declined enrollment. The registry record does not give enough outcome data to assess response completeness or the distribution of reasons.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a single-group design, a count-type primary outcome, and no analysis entries. It does not report the statistical methods used to analyze the outcomes. The explanations below are general statistical context, not a description of an analysis confirmed for this study.

What does a single-group design tell us?

General: A single-group study observes participants receiving an intervention without a concurrent control group. It can describe implementation, participation, and outcome patterns among those enrolled. If an outcome changes over time, a single-group design cannot, by itself, show that the intervention caused the change. Other influences, changes in measurement, and the natural course of outcomes may also contribute. A randomized comparison is generally used to estimate differences between groups under a specified design; this study has no such comparison.

In this record, allocation is not applicable and the study model is single-group. Thus, a treatment-versus-control effect is not available from the design. The registry also records no analysis entries, so it does not document an estimated within-group change or other statistical result.

How should a count outcome be understood?

General: Count outcomes are non-negative whole-number observations, such as the number of people reporting a reason. Their distribution can differ from the bell-shaped distributions often assumed for continuous measurements. Depending on the question and data, analysts may use methods designed for counts, or methods that compare observed counts with an expected reference. The choice depends on the outcome definition, follow-up, exposure, and analysis objective.

General: Over-dispersion occurs when count data vary more than a chosen statistical model expects. If it is ignored, standard errors can be too small and confidence intervals too narrow. A suitable analysis may account for extra variability, but the registry does not report a model or any assessment of dispersion. Here, the primary outcome is described as the number of people giving reasons for non-participation. The registry does not give the resulting count, denominator, or distribution, so no count model can be assessed.

What can estimates and uncertainty convey?

General: An estimate is a numerical summary of the observed data for a target quantity. A confidence interval expresses 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 the interval alone resolves limitations in design or measurement. A p-value, when reported, addresses compatibility of the observed data with a specified statistical null model; it is not a measure of clinical importance or the probability that a treatment works.

No estimates, confidence intervals, or p-values are reported in the registry record. There is consequently no basis to discuss the magnitude, direction, precision, or statistical significance of intervention-associated outcome changes. General statistical concepts cannot replace missing outcome results.

What do the planning illustrations mean?

General: Sample-size calculations are planning exercises based on assumptions about the target effect, variability, allocation, and statistical test. They do not describe the results of a trial. A calculation based on an observed effect can illustrate the number of participants that might be needed to detect an effect of a stated fraction of that estimate under specified assumptions. Such illustrations are especially sensitive to the uncertainty in the effect estimate used as their starting point.

The registry’s description of planning illustrations specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the target effect is a stated fraction of the observed effect. For time-to-event calculations, it describes total events; other calculations are described as participants per arm. These assumptions are explicitly characterized as planning illustrations rather than the trial’s own design. They do not change the fact that NCT05120843 is single-group and has no randomized comparator. The registry does not report its own sample-size justification or a planning analysis specific to this single-group design.

General: Power is a property of a design and a specified set of assumptions about a target effect and variability. It is not a measure of whether an observed result is reliable, and a planning illustration is not observed power. Because no analysis results are reported, no post hoc power claim or recalculated treatment effect can be interpreted for this study.

What is not documented?

The statistical analysis plan, model choices, covariate adjustments, handling of repeated measures, and approach to missing outcomes are not reported in the registry record. The record lists 11 outcome measures and 0 analyses. These registry entries indicate that outcome measures are registered but do not show that each was collected, analyzed, or reported. Without documented analysis methods and results, readers cannot verify how outcome data were transformed, compared, or interpreted.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 outcome measures, including the primary non-participation outcome and secondary outcomes concerning autonomy support, autonomous motivation, preventive care visits, and completion of recommended care. It records 0 analyses. The results of these outcomes and any analysis plan are not reported in the registry record. It is therefore not possible to determine which outcomes were analyzed, whether all planned analyses were performed, or how any results were selected for reporting.

When multiple outcomes or multiple statistical tests are examined, the chance of at least one apparently notable finding can increase. General methods for addressing this issue include defining a primary analysis in advance or adjusting inference across a family of tests. The registry record does not report whether a multiplicity strategy was planned or used. Since no test results are available, there is no basis to assess multiplicity-related interpretation in this study.

Missing-data methods and analysis populations are also not reported in the registry record. It does not say whether analyses were intended for all enrolled participants, only those with outcome data, or another defined group. It does not describe imputation, treatment of incomplete follow-up, or sensitivity analyses. For the primary outcome, women who decline enrollment were to be asked for reasons only if willing. The record does not report how many declined, how many responded, or whether nonresponse was addressed. That distinction matters because the number providing reasons may not represent all people who declined.

These omissions limit reproducibility and make it difficult to judge the completeness of outcome reporting. They do not establish that data were missing or that a particular analysis was biased; they mean that the registry record does not describe how such issues were handled.

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 adverse event record lists 13 participants at risk in the intervention arm, 0 serious adverse events, 0 other adverse events, and 0 deaths. No serious adverse event terms are listed. These are the reported counts for the group and event categories recorded in the registry.

General: A count of zero means that no events in that category were recorded for the stated group in the available record. It does not establish that an intervention is risk-free. Interpretation depends on how events were defined, how actively they were sought, the observation period, and whether all relevant events were reported. The registry record does not provide the adverse-event observation timeframe or detailed ascertainment procedures, so those aspects cannot be evaluated.

The study is single-group, with no control arm for comparative safety assessment. The counts therefore do not estimate a difference in adverse events between intervention and control. The record also does not provide event-level descriptions beyond the absence of listed serious terms. The figures should be read narrowly as recorded counts, not as proof that no harms occurred or that the intervention has a particular safety profile.

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

The registry record documents a study of care coordination and motivational interviewing for women with a recent preterm birth. Its stated purpose was to test implementation and refine the intervention, with a primary outcome focused on reasons women might decline enrollment and possible changes that could encourage participation. This focus makes the study relevant to feasibility and acceptability questions, rather than a direct estimate of clinical benefit.

The record does not report findings for the primary outcome or the listed secondary outcomes. It contains no analysis entries, estimates, confidence intervals, or hypothesis-test results. Therefore, it cannot establish whether participants’ autonomy support, autonomous motivation, preventive care visits, or completion of recommended care changed. Nor can it show whether decliners identified particular obstacles or suggested particular modifications.

The single-group design has no concurrent control group. General: Without a suitable comparison, observed changes cannot be separated from other influences with the same confidence as a controlled design permits. Even complete within-group results would answer a different question from whether outcomes differ because of the intervention.

The enrollment of 13 participants describes the recorded study enrollment, not the number who completed every measure or the number of women who were screened or declined. The status is terminated, but the reason is not reported in the registry record. The listed adverse event counts are also limited to the recorded categories and cannot establish the absence of unrecorded events or risks.

Accordingly, the record supports a careful description of the study’s intent, design, and recorded safety counts. It does not support a conclusion that the intervention works or does not work, that the study’s acceptability goals were met, or that the intervention is safe or unsafe. Those questions require outcome results and methodological detail that are not reported in the registry record.

13. Why This Trial Matters Statistically

Feasibility studies address practical questions that can shape later research: whether an intervention can be implemented, whether participants are willing to engage, and what changes might make study procedures more acceptable. This trial’s primary outcome was directed at one such issue by asking women who declined enrollment, if willing, to explain their reasons and suggest potential modifications. The record’s stated emphasis on implementation and refinement fits that purpose.

The statistical importance lies partly in distinguishing these aims from efficacy testing. A feasibility outcome can inform recruitment and intervention development without providing a treatment effect. The single-group open design is suitable for descriptive questions about participation and implementation, but it cannot provide a randomized estimate comparing intervention with control. Keeping the inferential question aligned with the design prevents a feasibility study from being read as a definitive clinical comparison.

The record also illustrates why outcome registration and outcome reporting are distinct. It names 11 outcome measures but records 0 analyses. Without results, methods, and denominators, readers cannot assess the observed patterns or their precision. The primary outcome description makes willingness to answer conditional, underscoring the importance of reporting who was approached, who declined, and who provided feedback. Those counts are not reported in the registry record.

Finally, recording termination and adverse event counts adds context, but neither resolves the absence of outcome analyses. The reason for termination and the duration and procedures for safety monitoring are not reported. Statistically, the most defensible reading is therefore bounded: the record describes an early-stage, single-group effort and its planned questions, while leaving the resulting evidence unavailable for assessment.

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 most important limitation for interpretation is that the registry record contains no analysis entries and does not report findings for the primary or secondary outcomes. The intended count of reasons for non-participation, the responses, and any themes are absent. As a result, the central acceptability question cannot be answered from this record.

The single-group open design has no control comparison, so it cannot estimate an intervention-versus-control effect. Enrollment is recorded as 13, but the number screened, eligible, approached, declining, completing the intervention, or contributing data to each outcome is not reported in the registry record. The reason for the terminated status is also not reported, leaving uncertainty about how termination affected recruitment, intervention delivery, or follow-up.

Important methods are undocumented, including the statistical analysis plan, sample-size justification, analysis populations, missing-data procedures, and any multiplicity strategy. The record does not describe outcome-specific estimates or their precision. It also does not report the adverse-event observation period or detailed event ascertainment procedures. These gaps prevent independent assessment of the completeness and robustness of results.

The primary outcome depends on voluntary feedback from women who decline enrollment. The number who were willing to answer and the extent to which their views represent all decliners are not reported. That limitation concerns the interpretation of the intended measure; the registry does not establish that a particular pattern of nonresponse occurred. The stated study purpose and design remain informative, but they do not supply outcome evidence in the absence of reported results.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth — NCT05120843.
• Registry record last updated 2026-01-27; status last verified 2026-01.
• Results first posted 2026-01-27.
• 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

NCT05120843, titled “Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth,” was a single-group open behavioral study. It tested care coordination combined with motivational interviewing for women with a recent preterm birth. The registry records 13 enrolled participants, a start date of 2022-02-03, a primary completion date of 2023-09-23, and a terminated status. The reason for termination is not reported in the registry record.

The primary outcome concerned reasons for non-participation and possible study modifications that might encourage enrollment. The registry lists 11 outcome measures and 0 analyses. Results for the primary and secondary outcomes, the analysis plan, and methods for missing data and multiplicity are not reported. The adverse event record lists 0 serious events, 0 other events, and 0 deaths among 13 participants at risk in the intervention arm. Without outcome analyses or a comparator, the record does not establish intervention effects.