Nurse-Led Interprofessional Mental Health Promotion Intervention for Older Home Care Clients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Nurse-Led Interprofessional Mental Health Promotion Intervention for Older Home Care Clients (NCT01407926), a registered phase not stated study. The primary outcome is Centre for Epidemiological Studies in Depression Scale.

2. Clinical Question

The study objective also includes evaluating feasibility and acceptability, but the posted results do not report findings for these aims. The registry record describes changes in anxiety, health-related quality of life, cognitive function, depression treatment, and health-service costs as additional interests. The posted record lists secondary measures including the Generalized Anxiety Disorder Screener and SF-12 indices. These outcomes broaden the study’s scope, but they do not resolve the main interpretive constraint: without a concurrent comparator, a measured change over time would not by itself isolate the intervention’s effect from other explanations.

3. Trial Design

The registry identifies NCT01407926 as a completed study sponsored by McMaster University. Its listed start is 2010-05 and its primary completion is 2013-06. The study is described as a one-group pre-test post-test evaluation of a nurse-led, interprofessional mental health promotion intervention among older home care clients with depressive symptoms who use personal support services.

The study description states an aim to recruit 250 clients, while the registry enrollment is 142. These figures describe the recruitment aim and the listed enrollment, respectively; they do not establish how many participants contributed data at each follow-up or to each outcome. The record does not report participant flow, follow-up completion, or the number included in any outcome analysis.

The intervention is described as a 6-month program involving regular home visits by a Registered Nurse and personal support worker, monthly case conferences, and assessment and management of depression using an interprofessional approach. The arm description adds that the nurse would assess health and screen for depression risk factors and other chronic conditions, then implement health-promotion strategies. The registry does not report how consistently these components were delivered or received.

Because there is no concurrent comparison group in the described design, the main estimand is a within-group change over time, not a randomized treatment contrast. Allocation is not stated, and the record does not describe a randomization procedure. It also does not report a protocol, detailed statistical analysis plan, or sample-size justification. The listed completion status indicates that the study is marked completed in the registry, but does not itself indicate whether all intended analyses or follow-up assessments were completed.

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: 12 months minus baseline value

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 Centre for Epidemiological Studies in Depression Scale, measured over Baseline to 12 months.

The primary outcome is the Centre for Epidemiological Studies in Depression Scale (CES-D), a continuous measure of depressive-symptom severity. The registry description states that it comprises 20 items and ranges from 0-60, with higher scores indicating greater symptom severity. The recorded parameter is a mean, and the stated dispersion is a 95% confidence interval. The primary outcome is described as a change in score, with the population field defining it as the 12 months minus baseline value.

As a general statistical point, a continuous scale can retain information about differences across its range rather than reducing results to a yes-or-no classification. A mean change can describe the average direction and magnitude of score change in the analysed group. A confidence interval conveys the precision of an estimate: narrower intervals indicate greater precision, while wider intervals indicate less precision, given the model and data used. Neither the mean nor its interval establishes that an intervention caused the change.

The registry’s own endpoint description says the CES-D has been used in prior trials involving older home care clients and describes it as reliable, valid, able to distinguish depressed from non-depressed people, and sensitive to change over time in psychiatric populations. These are statements in the record, not results of the present study. There is a timeframe inconsistency: the study summary calls the primary outcome change from baseline to 6 months, whereas the listed primary outcome specifies Baseline to 12 months. The record does not clarify which timeframe governed the primary analysis.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General: What does a one-group pre-test post-test design estimate? A pre-test post-test design measures an outcome before and after an intervention in the same group. Its most direct description is the change between the recorded measurements for the participants included in the analysis. The record identifies this study as one-group and does not describe a concurrent comparator. Thus, the design can document a pattern of change over time, but it cannot separate intervention-related change from all other influences that may operate over that period. A comparison against each participant’s baseline is not the same as a comparison against what would have happened without the intervention.

General: What does a mean change represent? The CES-D is treated in the registry as a continuous scale, and the outcome parameter is a mean. A mean change combines individual changes into an average for the analysed group. It can be useful for describing the overall pattern, but it does not show whether every participant changed in the same direction. The mean also does not describe the full distribution of scores. Interpretation depends on the score definition, the time points used, the participants included, and the analysis approach. The registry record does not provide the observed mean change or the data needed to inspect these features.

General: How should a confidence interval be read? A confidence interval expresses uncertainty around an estimated quantity under the method used to calculate it. It is not a guarantee that the true value lies within the interval, nor does it address biases caused by study design or missing data. The registry names a 95% confidence interval as the planned dispersion for the primary mean. However, no interval is posted for the primary outcome. Without an estimate and its interval, statistical precision cannot be judged, and the data cannot be assessed for a range of values compatible with the analysis.

General: Why does the absence of a comparator matter? A change from baseline may coincide with the intervention, but coincidence does not identify the cause of change. Over time, symptoms may change for reasons unrelated to the program, and participants may receive other care. Measurement variation and selective follow-up can also affect observed results. A concurrent comparator can help account for changes common to both groups, provided the comparison is appropriately designed and analysed. No such group is described in this registry record. Therefore, even if a within-group change estimate were available, it would not by itself establish the change attributable to the intervention.

General: What do the planning assumptions mean? The registry describes a sample-size illustration as a planning exercise based on an observed effect, not the trial’s own design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. The same record describes the actual study as a one-group pre-test post-test study. These hypothetical two-arm assumptions should not be mistaken for the design used in the study or as evidence that the study had a particular power. The registry does not report the underlying observed effect or the sample-size illustration’s numeric outputs in the registry record for interpretation. Any such planning figure is an illustration for a possible future comparison, not observed power and not a result from the enrolled group.

General: What does over-dispersion mean? For count outcomes, over-dispersion means that observed variability is greater than a model assumes. Ignoring it can make standard errors too small and confidence intervals too narrow. This concept does not appear to describe the primary CES-D outcome, which is recorded as a continuous measure with a mean. The registry record does not report an analysis model for the primary outcome, so it is not possible to say what variance assumptions or adjustments were used.

What analysis details are available? The registry lists the primary measure, its mean parameter, its 95% confidence interval, and a stated change from baseline. It does not report an inferential test, a model specification, covariate adjustment, handling of repeated measurements, or an analysis population. It also does not report whether the primary analysis was based on all enrolled participants or only those with the relevant follow-up measurement. These omissions prevent a detailed assessment of how the outcome estimate would have been constructed, even if a result were posted.

Why does the endpoint timing need clarification? The study summary describes the primary change as baseline to 6 months, while the listed outcome specifies Baseline to 12 months. The intervention itself is described as lasting 6 months, but that does not determine the analysis time point. A reader cannot assume that either timeframe supersedes the other. The registry record does not explain whether the discrepancy reflects a change in plans, an outcome-entry error, or a difference between intervention duration and follow-up. The distinction matters for a change estimate because it defines the interval over which the measurement changed.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 12 outcome measures and describes several secondary outcomes, including anxiety and multiple SF-12 indices. When a study evaluates several outcomes, multiplicity can arise because repeated statistical tests increase the chance of obtaining a nominally unusual result by chance. General approaches include identifying a primary outcome in advance, adjusting for multiple comparisons, or treating secondary results as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or whether any adjustment was planned. With no posted analyses or outcome estimates, it is not possible to assess how multiplicity was handled in practice.

Missing-data handling is also not reported in the registry record. Enrollment is listed as 142, but the record does not state how many participants contributed baseline and follow-up scores, whether reasons for missing assessments were recorded, or how missing values were treated. Complete-case analysis, imputation, and models that use available repeated measurements rely on different assumptions. These are general methods; the record does not identify which, if any, was used. The effect of missing observations on the estimated change therefore cannot be assessed.

The analysis population is not reported in the registry record. It does not state whether all enrolled participants were included in the primary analysis, whether eligibility or intervention participation affected inclusion, or whether analyses used a defined subset. No participant-flow account is posted. These details matter because an estimate based only on those with follow-up measurements may not represent everyone enrolled if completion is related to symptoms or other factors.

The registry lists 0 analyses, so it does not provide results with denominators, missing-data methods, or adjusted and unadjusted estimates. The endpoint timeframe is also unclear: the study summary describes baseline to 6 months, whereas the outcome entry specifies Baseline to 12 months. Without clarification, readers cannot determine which follow-up measurement would define the primary analysis.

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 the Nurse-Led Mental Health Promotion Group with 142 participants at risk for serious adverse events and 0 affected. It also lists 142 at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse-event terms are listed. These are registry counts for the group; they are not comparative estimates against an untreated or alternative-treatment group.

A zero count in the posted record means that no events are recorded in that category in this entry. It does not establish that an intervention is free of risk. The record does not describe event definitions, the period over which events were collected, the method of surveillance, or whether every participant contributed safety information for the same duration. It also does not provide a confidence interval or other measure of uncertainty around these counts.

Because the study is described as one-group and has no concurrent comparator, the counts cannot show whether event frequency differed from what would have occurred without the program. The figures should be read as registry-reported safety observations, not as proof of safety or as a comparative safety conclusion.

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

The record describes a completed evaluation of a 6-month nurse-led, interprofessional mental health promotion program for older home care clients with depressive symptoms. It identifies the CES-D as the primary measure of depressive-symptom severity and lists 142 as enrollment. Those details establish the study’s topic, design, and recorded enrollment; they do not establish the intervention’s effect.

The primary outcome result is not reported in the registry record. There is no numerical mean change or confidence interval with which to evaluate the direction, magnitude, or precision of change. The record also does not report findings for feasibility, acceptability, or the secondary outcomes. It is therefore not possible to say from this record whether scores improved, worsened, or remained similar, or whether any observed change would be clinically important.

Even if a within-group change were reported, the one-group pre-test post-test design would support a description of change over time, not a definitive causal estimate. Without a concurrent comparator, other explanations for changes cannot be ruled out. The registry’s hypothetical sample-size illustration does not change this limitation: it is described as planning for a possible two-arm comparison, rather than as an analysis of the study design.

The primary timeframe is ambiguous. The study summary refers to baseline to 6 months, while the outcome entry specifies Baseline to 12 months. The record does not explain the difference. Nor does it report the analysis population, missing-data approach, or multiplicity handling. These omissions limit both reproducibility and assessment of bias or uncertainty.

The posted adverse-event entry records 0 serious events, 0 other events, and 0 deaths in the intervention group, with 142 listed at risk in each event category. Those counts should not be taken as proof that no risk exists, particularly without details of event ascertainment or a comparison group. Overall, the registry record documents an intervention and its intended evaluation, but does not provide the outcome evidence needed to judge its observed effects.

13. Why This Trial Matters Statistically

This trial is statistically notable because it evaluates a complex service intervention in a population receiving home care, while using a one-group pre-test post-test design. The design can be useful for describing whether scores and other measures change during an intervention period. It also makes clear why the distinction between within-group change and a comparative treatment effect matters: a before-and-after pattern does not by itself identify what caused the pattern.

The primary outcome is a continuous symptom scale, and the registry specifies a mean change with a 95% confidence interval. This setup points to two important questions for interpreting a result: how large is the estimated average change, and how precisely is it estimated? Neither can be answered from the posted record because numerical outcome estimates are absent. This is a practical reminder that an outcome’s name and planned summary are not substitutes for reported results.

The registry also illustrates how differences within a record can affect interpretation. The study description names baseline to 6 months for the primary outcome, while the outcome entry specifies Baseline to 12 months. A clear endpoint and time point are essential for defining the estimand and understanding which observations should contribute to an analysis. The record does not resolve this discrepancy.

Finally, the entry lists multiple outcome measures and describes a planning illustration based on a hypothetical two-arm comparison, although the study itself is described as one group. Separating the actual design from planning assumptions, and distinguishing planned outcomes from analysed results, is central to sound statistical reading. The record leaves these issues and key analysis details unreported, making transparent interpretation especially important.

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 limitations specific to this record constrain interpretation beyond the general limits of a one-group design. First, the primary endpoint timing is inconsistent: the study summary says baseline to 6 months, while the primary outcome entry says Baseline to 12 months. The registry does not explain which time point was intended or analysed. This makes the primary estimand uncertain.

Second, the registry lists 142 participants enrolled but gives no participant-flow information, follow-up denominators, or outcome estimates. It is not possible to determine how complete the primary or secondary assessments were, or whether missing observations could have influenced the findings. The record’s 0 analyses further limits assessment of the completed study’s results.

Third, the description of the intended sample size and the listed enrollment are different, but the record does not explain recruitment progress, reasons for the difference, or whether the study design or objectives changed. The sample-size illustration is explicitly described as a planning exercise based on an observed effect and hypothetical two-arm assumptions; the registry does not provide enough information to assess its relevance to the one-group study.

Fourth, allocation is not stated, and no comparator is described. The intervention combines multiple components, including home visits, case conferences, and assessment and management, but fidelity, adherence, and exposure are not reported. The effect of any individual component could not be separated from the others using the description alone.

Finally, the analysis plan, multiplicity approach, missing-data methods, and analysis population are not reported in the registry record. These gaps, together with the absence of numerical outcome results, prevent evaluation of statistical precision, robustness, and potential selective reporting. The listed completion status does not address these reporting limitations.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Nurse-Led Interprofessional Mental Health Promotion Intervention for Older Home Care Clients — NCT01407926.
• Registry record last updated 2019-06-07; status last verified 2019-03.
• Results first posted 2019-06-07.
• 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

NCT01407926 is a completed study sponsored by McMaster University, with a listed start of 2010-05 and primary completion of 2013-06. It evaluates a nurse-led, interprofessional mental health promotion intervention for older home care clients with depressive symptoms. The study is described as one-group pre-test post-test, with a planned 6-month intervention involving home visits and other interprofessional activities.

The registry lists enrollment of 142 and identifies the CES-D as the primary outcome measure. The primary timeframe is inconsistent across the record: the study description states baseline to 6 months, while the outcome entry specifies Baseline to 12 months. Although the registry lists 12 outcome measures, it records 0 analyses and does not report numerical outcome estimates. The adverse-event entry lists 0 serious events, 0 other events, and 0 deaths.

Accordingly, the registry record documents the study’s aims, intervention, and outcome measures, but does not provide results sufficient to assess change or draw conclusions about effectiveness.