Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI) (NCT04612842), a randomized na study. The primary outcome is Falls Self-Efficacy Scale-International (FES-I) Results.

2. Clinical Question

The study concerns a behavioral communication approach delivered after participants had received fall-prevention recommendations. Its main statistical question is longitudinal: whether self-reported concern related to preventing falls changes across follow-up, and how the observed pattern is described in the randomized groups. The record characterizes the study as a mixed-methods, two-arm randomized controlled trial. It does not report enough outcome estimates to describe the size, precision, or direction of any between-group difference. Nor does it report detailed eligibility criteria or a more specific definition of the target population beyond older adults receiving recommendations at the named clinic.

3. Trial Design

This was a randomized, parallel-group trial with two arms and no masking. The registry record lists the study as completed and records enrollment of 200. Oregon Health and Science University was the sponsor. The recorded study start was 2020-09-09 and primary completion was 2023-03-24.

The intervention was behavioral: motivational interviewing about fall prevention. The MI group was described as receiving the same measurements as the control group, with MI-based communication added at eight occasions during the 6-month period. The control group description specifies study measurements over 12-months, including self-report and physiologic assessment. Its primary assessments are described as occurring at baseline, 6-, and 12-months, using phone survey, video assessment, or a mail-in calendar.

The primary outcome timeframe is separately listed as 3-, 6-, and 12-months. The registry record does not explain the difference between that timeframe and the control-arm description of assessment timing. It also does not report the randomization sequence method, allocation concealment, or whether the groups were assigned in equal numbers. The equal-allocation assumption described for planning illustrations is not evidence of the trial's actual allocation ratio.

The brief summary characterizes the trial as mixed-methods and says it evaluates MI as follow-up care for patients who received fall-prevention recommendations at the clinic. Details of any qualitative component are not reported in the registry record. Eligibility criteria, recruitment procedures, and the extent to which participants received other fall-prevention care are also not reported. These details would help clarify the population and the context in which the intervention was delivered.

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: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below looks different from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)

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 Falls Self-Efficacy Scale-International (FES-I) Results, measured over 3-, 6-, and 12-months.

The primary outcome is the Falls Self-Efficacy Scale-International (FES-I). It is a 7-item self-report scale, with each item rated from 1-4. The stated minimum value is 7 and the maximum value is 28. The registry describes the scale as measuring levels of concern related to preventing falls. Higher FES-I scores are considered worse values because the record says they have been positively correlated with decreased activities, future falls, and injury.

A continuous score captures differences across a range rather than sorting participants into only a few outcome categories. The registry lists the outcome parameter as a mean and its dispersion as a standard error. A mean describes the average score in the analytic data; a standard error describes the precision of an estimated mean, not the spread of individual scores. Neither statistic alone establishes whether groups differ meaningfully.

Repeated FES-I measurements can describe whether average scores change over follow-up and whether the groups have different patterns. The record identifies 3-, 6-, and 12-months as the primary outcome timeframe. Numerical means, standard errors, and between-group estimates are not reported in the registry record. The endpoint description therefore explains what the measure is intended to represent, but does not establish the observed outcome pattern.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous, and the registry says that changes over time were assessed with mixed-effect modeling. The record describes the model approach at a high level, but it does not report the model formula, the exact contrast used, or the numerical estimates. General explanations of these methods can clarify what the approach is designed to do without establishing which options were used in this trial.

What does a mixed-effects approach do?

In general, a mixed-effects model can analyze repeated measurements while accounting for the fact that observations from the same participant are related. Measurements from one person are not usually independent of one another: a participant's scores may share characteristics that distinguish them from other participants. A model can represent the average outcome pattern while also allowing for participant-level variation. The specific structure used in this trial is not reported in the registry record.

Modeling change over time can use information from participants with measurements at different follow-up occasions. The registry states that the analytic sample includes participants with an outcome measure at at least one time point. That inclusion statement does not reveal how the model represented time, whether time was categorical or continuous, which baseline or other covariates were included, or what assumptions were made about the relationship among repeated scores. These details are not reported.

What does the standard error describe?

The registry lists the outcome parameter as a mean and the dispersion measure as a standard error. In general, the standard error describes the sampling precision of an estimated mean. It is not a summary of how far individual participants' scores vary from one another. A confidence interval is commonly used to express uncertainty around an estimate by presenting a range of values compatible with the data and model assumptions. The registry record does not report a confidence interval for the primary outcome, nor does it provide the numerical means or standard errors needed to assess precision.

How should repeated assessments be interpreted?

Assessments at multiple times make the interpretation longitudinal. One can ask whether scores change over follow-up within groups, whether groups differ at a particular follow-up, or whether their patterns of change differ. These are different statistical questions. A difference in change is not necessarily the same quantity as a difference in scores at one time point. The record does not identify a single comparison for the primary outcome; it notes that the outcome has several categories or time points and is not reduced to one comparison. The exact estimated contrasts are not reported in the registry record.

General interpretation also depends on the scale direction. For this FES-I measure, higher scores are described as worse values. Thus, the sign of an estimated contrast would need to be interpreted with that direction in mind. Since no numerical estimates are reported, no direction can be assigned to the trial's observed effect.

What is not specified about the analysis?

The registry says that an intent-to-treat analysis was conducted, but the accompanying description is incomplete. It also says the mixed-effect analysis includes participants with an outcome measure at at least one time point. The record does not report the precise analysis population rules beyond this statement, how deviations from assigned groups were treated, or the assumptions and procedures used for missing outcome data.

Other details not reported include the model's link or distributional specification, covariance structure, adjustment variables, handling of protocol deviations, and whether estimates were adjusted for baseline scores. This list describes possible analytic details, not claims about what the investigators did. General statistical principles cannot fill in missing trial-specific methods.

The registry's planning illustration is described as using the observed effect, a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; it is intended to estimate participants per arm for a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial used those assumptions in its original design. The registry record does not report the trial's own sample-size justification. Such illustrations are not observed power and do not replace the outcome estimates, uncertainty intervals, or analysis details needed to interpret the primary result.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 outcome measures, including the primary FES-I outcome and secondary measures related to patient activation, confidence and importance concerning fall prevention, balance, and sit-to-stand performance. The primary outcome is assessed over 3-, 6-, and 12-months, so interpretation potentially involves more than one time-specific estimate. Multiple outcomes and time points can create multiple opportunities to observe apparently notable findings, even when no single finding is conclusive.

In general, multiplicity refers to the interpretive problem created by making several statistical comparisons. A prespecified primary contrast and an explicit adjustment strategy can help clarify which results are confirmatory and how uncertainty is handled. The registry record does not report a multiplicity adjustment, a hierarchy among time-specific comparisons, or which secondary outcome comparisons were considered confirmatory. It would be inappropriate to assume that an adjustment was or was not used in analyses beyond what is recorded.

For missing data, the registry states that mixed-effect modeling used participants with an outcome measure at at least one time point, and notes that this analytic sample differs from participant-flow data. This describes an inclusion feature, not a complete account of missingness. The record does not report reasons for missing assessments, missingness patterns by group, or the assumptions and procedures used to address missing outcomes. General mixed-effects methods can use incomplete repeated measurements under particular assumptions, but they do not automatically eliminate bias if those assumptions are unsuitable.

The record also says an intent-to-treat analysis was conducted, but the accompanying wording is incomplete. Further details about how participants were analyzed in relation to their randomized group are not reported in the registry record. These gaps matter because the meaning of an estimate depends on both the comparison selected and the participants and observations included.

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: falls (major) (7.1%), death (2.0%), orthostatic hypotension (1.0%), urinary tract infection (1.0%), heart surgery (1.0%).

The registry reports serious adverse event counts for the Motivational Interviewing (MI) Group and the Control Group. For serious events, 101 participants were listed at risk and 11 affected in the MI group; 99 were listed at risk and 13 affected in the control group. For other adverse events, the corresponding figures are 101 at risk and 54 affected in the MI group, and 99 at risk and 62 affected in the control group. Deaths are listed as 2 in each group.

These are registry-reported counts, not estimates of a causal treatment effect. The figures alone do not show whether an event was caused by the intervention, whether participants experienced more than one event, or how event timing related to study activities. The record does not provide enough detail to infer those relationships.

The registry's listed serious-event terms include Falls (major) at 7.1%, Death at 2.0%, and Orthostatic hypotension, Urinary tract infection, Heart surgery, and Deep vein thrombosis at 1.0% each. The denominator and calculation details for these listed percentages are not reported in the registry record. They should not be interpreted as group-specific risks or compared across groups without that context. Event counts and listed terms describe what was recorded; they do not by themselves establish comparative safety or causation.

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

This trial record describes a randomized comparison of motivational interviewing as follow-up fall-prevention communication against a control condition centered on study measurements. Its primary endpoint is the FES-I, a self-report measure of concern related to preventing falls. The outcome is assessed over time, and higher scores are defined as worse values. These features explain what the study set out to evaluate, not what the observed results were.

The numerical primary-outcome estimates are not reported in the registry record. Without group means or contrasts and their uncertainty, the direction and magnitude of any outcome difference cannot be characterized. The available information also does not establish whether any observed difference, if present, was precise, clinically important, or robust to analytic choices.

Random assignment is a design feature intended in general to support comparison between groups by reducing systematic differences at assignment. It does not ensure identical groups on every characteristic, and the registry record does not give the allocation method or detailed baseline data. The absence of masking is recorded, but the record does not describe how that feature affected participant reporting, assessment, or other trial procedures.

The secondary outcomes and safety counts provide additional descriptions of what the trial assessed and recorded. They do not fill the gap in the primary outcome estimates or establish that the intervention caused a change in any measure. The serious adverse event figures are counts, and the registry does not report the causal attribution or denominator details needed for broader comparative interpretation.

Overall, the record supports a careful account of trial structure, measurement, and analysis population description. It does not support a conclusion that MI did or did not change fall-related concern, nor does it establish clinical benefit or harm. Such conclusions would require outcome estimates, uncertainty, and fuller analytic and safety reporting.

13. Why This Trial Matters Statistically

This trial raises a statistical question that is common in behavioral and clinical research: how to compare outcome patterns when a continuous measure is collected repeatedly over follow-up. A longitudinal endpoint is not just a single score. Interpretation can depend on the time point, the contrast of interest, the relationship among observations from the same participant, and the way incomplete follow-up is handled.

The registry's mixed-effect modeling description signals that repeated measurements were considered, while its analytic-sample statement clarifies that participants with an outcome at at least one time point could be included. Those details are useful for understanding the broad analytical frame. At the same time, the absence of the model specification, estimated contrasts, and uncertainty intervals prevents readers from judging how the analysis translated the repeated scores into a result.

The scale's direction is also important. Higher FES-I values are designated as worse, so any reported estimate would need to be interpreted with that coding in mind. The record gives that interpretation but not the numerical results needed to apply it.

Finally, the trial illustrates why an outcome schedule and a defined primary comparison matter. The primary endpoint is listed at 3-, 6-, and 12-months, while an arm description gives a different schedule for primary assessments. The registry does not explain the discrepancy or identify a single summary comparison. Clear reporting of assessment timing, target contrast, missing-data assumptions, and multiplicity handling would make a longitudinal result easier to evaluate. The record's planning illustration should likewise be distinguished from trial evidence: assumptions used to illustrate future sample sizes do not indicate observed power or resolve uncertainty about the outcome.

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.

Several trial-specific details needed for a complete interpretation are not reported in the registry record. Eligibility criteria are not described in detail, so the characteristics defining the target population cannot be fully assessed. The randomization sequence and allocation concealment methods are also not reported. The study is listed as having no masking, but the registry does not explain which people involved in assessment or analysis knew group assignment.

The primary outcome schedule is not fully clear. The endpoint timeframe is recorded as 3-, 6-, and 12-months, while the control-arm description gives primary assessments at baseline, 6-, and 12-months. The reason for this difference is not reported. The analysis is described as using participants with an outcome measure at at least one time point, but attrition counts, reasons for missingness, and the method used to address missing data are not reported in the record.

Numerical primary outcome estimates and uncertainty measures are not reported in the registry information. The model's specific form, covariate adjustment, contrast definition, and multiplicity strategy are also not reported. The intent-to-treat description is incomplete, limiting assessment of the analysis population.

The brief summary calls the study mixed-methods, but the qualitative methods and findings are not described in the record. The adverse-event percentages are listed without denominator and calculation details. These limitations do not establish that the trial was conducted improperly; they identify information gaps that constrain interpretation of the posted record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI) — NCT04612842.
• Registry record last updated 2024-08-13; status last verified 2024-07.
• Results first posted 2024-08-13.
• 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 record describes NCT04612842, Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI), as a completed randomized, parallel, two-arm trial with no masking. Enrollment is recorded as 200, and Oregon Health and Science University is listed as sponsor. The recorded study start is 2020-09-09 and primary completion is 2023-03-24.

The intervention was MI-based fall-prevention communication on eight occasions during the 6-month period, alongside study measurements. The primary outcome was FES-I, a self-report scale on which higher values are described as worse. The record says mixed-effect modeling assessed changes over time and that the analytic sample included participants with an outcome at at least one time point.

Numerical primary outcome estimates, uncertainty intervals, detailed model specifications, and a complete missing-data and multiplicity account are not reported in the registry record. The record therefore supports a description of the study design and endpoint, but not a conclusion about the observed primary outcome effect.