A Multidomain Intervention Program for Older People With Dementia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Multidomain Intervention Program for Older People With Dementia (NCT04948450), a randomized na study. The primary outcome is Adherence.

2. Clinical Question

The study description also sets out hypotheses about cognition, quality of life, behavior, functional ability, sleep, falls, and death rate. These are hypotheses in the registry summary, not findings. The record lists secondary outcomes including global cognition, clock drawing, digit span, behavioral and psychological symptoms of dementia, Barthel Index dependence, handgrip strength, and a 30 seconds sit to stand test. It does not post a comparative result for these outcomes in the displayed results.

The main statistical question that can be answered from the posted primary result is therefore descriptive: what percentage of planned intervention sessions did participants attend? The record does not allow an estimate of whether the intervention improved health outcomes relative to regular health advice.

3. Trial Design

This is a completed pilot study with randomized allocation and a parallel-group design. The registry record describes triple masking but does not identify which people or roles were masked, or how masking was maintained. Enrollment is listed as 60. The study summary says participants were to be randomized into two equal groups; the posted safety figures list 30 participants at risk in each group.

The intervention is multidomain. Registered components include physical activity, cognitive stimulation, social intervention, and management of metabolic and vascular risk factors. The arm description specifies progressive resistance training at the nursing home and cognitive intervention based on Cognitive Stimulation Therapy with rehabilitation experts. The control group received general health advice every 3 months based on physical examination and blood results, along with information and instruction concerning vascular risk factors, diet, and exercise. The registry does not report the schedule or delivery detail for every intervention component.

The primary outcome timeframe is 6 months, matching the intervention period described in the study summary. The primary outcome is adherence, defined as the percentage of sessions attended out of the total planned, and it was assessed only in the intervention group. The registry lists secondary outcomes concerning cognition, behavior, dependence, and physical function.

The study start is listed as 2022-11-24, primary completion as 2024-01-31, and status as completed. The registry record does not report the random-sequence method, allocation concealment, or the identities of the masked parties. It also does not report the sample-size justification or a detailed statistical analysis plan. The design supports a feasibility question, but the posted primary result does not furnish a randomized comparison of adherence or of clinical outcomes between groups.

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: Adherence was only assessed for the intervention group

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 Adherence, measured over 6 months.

The primary endpoint is adherence over 6 months, expressed as the percentage of planned sessions attended. The registry description defines the measure as the percentage of sessions attended out of the total planned. It is assessed only for the intervention group, so it describes participation in the intervention rather than a contrast between randomized groups.

Adherence is useful in a pilot study because it indicates whether participants attended the planned intervention sessions. It can help describe the practical feasibility of delivering and taking part in a program. As a general statistical point, a percentage is easier to interpret when its numerator and denominator, observation period, and handling of participants with incomplete follow-up are clear. The registry gives the measure’s general definition and a 6 months timeframe, but it does not report the total planned session count, participant-level adherence values, or how incomplete attendance was handled.

The posted result is 85.4% for the intervention group, with 30 participants listed. No spread measure or confidence interval is reported. The control group has no adherence value because the registry says adherence was assessed only in the intervention group. This endpoint therefore cannot establish a between-group difference. Nor does attendance itself show whether cognition, function, or other health outcomes changed.

The outcome is aligned with a feasibility aim, but the registry record does not report a threshold defining acceptable adherence or a decision rule for judging feasibility. Interpretation should remain descriptive: the posted figure summarizes attendance under the study’s measure, without a reported estimate of its precision or a comparative clinical effect.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group, triple-masked pilot study. These design labels describe how the study was organized; they do not, by themselves, tell us how well randomization or masking worked in practice. The registry record does not report the sequence-generation method, allocation concealment, or which participants, clinicians, assessors, or analysts were masked. Those details matter when judging the potential for selection, performance, or assessment bias.

What the posted endpoint summarizes

The primary outcome is a count-based percentage: sessions attended divided conceptually by the total planned sessions, expressed as a percentage. The registry’s definition is the percentage of sessions attended out of the total planned. The posted value is 85.4% for 30 participants in the intervention group. A percentage condenses attendance information into a single summary, but it does not show whether attendance was similar across participants or concentrated among a subset. Without the underlying counts or participant-level distribution, those patterns cannot be examined.

The registry does not give a spread estimate or confidence interval for the adherence result. In general, a confidence interval gives a range of values compatible with the data and the assumptions of the method; it communicates uncertainty rather than guaranteeing that the true value falls within the interval. No such interval is posted here, so the precision of the 85.4% estimate cannot be read from the results. The registry also does not explain how participants who missed visits, withdrew, or had incomplete attendance records were handled.

Why the endpoint is not a group comparison

Although participants were assigned to two groups, adherence was assessed only in the intervention group. There is therefore no control-group adherence result to compare with the intervention-group value. A randomized comparison requires an outcome measured in a way that supports a contrast between the assigned groups. The displayed adherence result instead describes attendance in the group offered the multidomain program. It does not estimate a treatment effect.

The record categorizes the primary outcome as a count-other outcome and says the posted data are not reduced to one comparison. In plain terms, the available summary does not yield a single between-group estimate for this outcome. No comparative effect, uncertainty interval, or significance test is posted. A statistical test cannot recover a comparison that the reported outcome structure does not support.

Interpreting the pilot design

A pilot study can focus on whether an intervention and its procedures can be implemented, rather than on a definitive estimate of clinical benefit. Here, the stated feasibility focus and adherence endpoint are consistent with describing participation in the intervention. The registry does not report a formal feasibility threshold, a sample-size justification, or a decision rule for judging whether adherence would be acceptable. It is therefore not possible to determine from the record whether 85.4% met a prespecified criterion.

General statistical principle: a planning sample size is not a measure of power observed after the study. The sample-size section presents planning illustrations based on the observed effect, with stated assumptions about significance level, allocation, and a normal approximation. Such illustrations are hypothetical planning calculations, not a claim that the completed trial had a particular probability of detecting an effect. The registry record does not report the trial’s own sample-size justification.

Secondary outcomes and multiplicity

The registry names outcomes covering global cognition, executive function measured by clock drawing, attention measured by digit span forward and backward, behavioral and psychological symptoms, dependence assessed by the Barthel Index, handgrip strength, and the 30 seconds sit to stand test. The record reports 14 secondary outcomes posted and 16 outcome measures overall. The displayed results do not provide estimates for those secondary outcomes, and no analyses are listed. It is therefore not possible to assess effect sizes, precision, or consistency across outcomes.

General statistical principle: when many outcomes are tested, the chance of at least one apparently notable result can increase if each is judged separately. Researchers may address this through a prespecified hierarchy, adjustment, or a clear distinction between primary and exploratory analyses. The registry record does not report a multiplicity strategy, so readers cannot determine how multiple outcome tests were to be interpreted. This point is especially relevant to the stated hypotheses across several domains, but it does not justify assuming that unreported analyses occurred.

What can be concluded statistically

The posted primary result supports a descriptive statement about intervention attendance only. Its uncertainty is not quantified, the control group has no matching adherence result, and no clinical outcome comparison is posted. The safety entries report zero events in the listed categories, but the record does not give enough detail to infer precise comparative risks. Any broader interpretation would require results or methods not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists several secondary outcomes in addition to the adherence endpoint. These include measures of cognition and attention, behavioral and psychological symptoms, dependence, and physical function. It reports 14 secondary outcomes posted and 16 outcome measures overall, but no analyses are listed in the posted results. The displayed record therefore does not allow readers to examine which outcomes were analyzed, how many comparisons were made, or whether results were selected for reporting.

As a general statistical matter, testing multiple outcomes can make isolated findings harder to interpret. A prespecified primary outcome, a hierarchy of outcomes, or an adjustment for multiple comparisons can clarify how evidence across endpoints should be evaluated. The registry record does not report a multiplicity procedure or a statistical analysis plan. It is not possible to infer that a particular adjustment was used, or that the listed outcomes were all tested.

Missing-data handling is also not reported in the registry record. For adherence, the record does not explain the treatment of incomplete attendance or the denominator used for participants without a complete record. For secondary outcomes, it does not describe missing measurements, exclusions, or imputation. The analysis populations are not reported in the registry record, so it is unclear which participants would have been included in any outcome analysis.

The displayed result identifies 30 intervention participants for adherence, but it does not give a participant flow or explain whether all randomized participants contributed to that summary. These omissions limit assessment of potential bias and precision. They should be treated as reporting uncertainties, not as evidence that data were missing or that a particular analysis population was 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 reports serious adverse events, other adverse events, and deaths separately for the intervention and control groups. Each group is listed as having 30 participants at risk. The reported affected counts are 0 for serious adverse events, 0 for other adverse events, and 0 deaths in each group.

These figures mean that the posted results record no events in those categories for the listed participants at risk. They do not prove that the underlying risk is zero. A zero count can occur in a study even when an event remains possible, and the record gives no uncertainty interval for these counts. It also does not specify event definitions, severity grading beyond the serious/other categories, follow-up exposure time, or how events were collected.

Because both arms have the same reported counts, the displayed safety summary does not show a numerical difference between groups. It is still a limited description, not a precise estimate of relative or absolute risk. The registry does not list serious-event terms or provide narrative details. These entries should be read as the adverse-event information posted in the record, rather than as a comprehensive account of safety.

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

The result does mean that the registry posts an adherence summary of 85.4% for the intervention group over 6 months, with 30 participants listed. The outcome is defined as the percentage of planned sessions attended. It gives a descriptive account of participation in the program as recorded by the study.

It does not show how attendance varied among participants, because participant-level results and a spread measure are not reported. It also does not show the uncertainty around the percentage: no confidence interval is posted. The total number of planned sessions and the underlying attended-session count are not reported, and the registry does not explain how incomplete attendance records were handled.

The result does not compare intervention-group adherence with control-group adherence. The registry explicitly states that adherence was assessed only for the intervention group. Thus, the randomized design does not turn this endpoint into a comparative estimate. Nor does the adherence percentage establish that the program changed cognition, behavior, function, sleep, falls, death rate, or quality of life. The study summary names these as hypotheses, while the displayed results do not report comparative effects for them.

The registry’s zero event counts in both arms are also descriptive. They do not demonstrate an absence of risk or provide a precise safety comparison. The record does not report confidence intervals or fuller event details.

Overall, the posted information supports a limited reading of feasibility-related attendance and recorded adverse-event counts. It does not support conclusions about clinical efficacy, a causal effect on the listed secondary outcomes, or the precision of the adherence estimate. The registry record does not report the statistical analysis plan, missing-data approach, or analysis populations needed for a fuller assessment.

13. Why This Trial Matters Statistically

This trial is statistically notable for the difference between its broad clinical hypotheses and the narrow primary result posted in the registry. The study description proposes a multidomain intervention and names possible changes across cognition, quality of life, behavior, function, sleep, falls, and death rate. The reported primary endpoint, however, is attendance in the intervention group. That measure addresses participation, not comparative clinical outcomes.

For a pilot study, feasibility information can be important in its own right. The adherence result gives readers a summary of engagement with the intervention, while the randomized parallel-group design establishes that the study was organized to include a control group. Yet the endpoint was not assessed in the control group, and the displayed result cannot use randomization to estimate a between-group difference. This illustrates why the choice and reporting of endpoints determine which questions can be answered.

The trial also highlights the importance of reporting uncertainty. A percentage without a confidence interval or distribution of participant-level values may appear precise while leaving its sampling variability unclear. The registry’s secondary outcome list signals the breadth of planned measurement, but the absence of posted estimates and analyses means that readers cannot assess those outcomes or their consistency.

Finally, the record illustrates the distinction between a stated hypothesis, a result, and a planning calculation. The hypotheses are not findings, and sample-size illustrations are not observed power. Clear reporting of the analysis plan, outcome data, missingness, and uncertainty would be needed to move from a feasibility description toward stronger statistical interpretation.

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 interpreting this specific record is that the primary adherence endpoint is reported only for the intervention group. The result is therefore not a randomized comparison, even though the study used randomized allocation. No control-group adherence value is posted.

The adherence summary is reported as 85.4% for 30 participants, but the registry does not provide a confidence interval, spread measure, participant-level values, or the underlying counts of attended and planned sessions. The record also does not explain how incomplete attendance was handled or whether all randomized participants contributed to the summary. These omissions prevent assessment of precision and variation in engagement.

The registry lists a range of secondary outcomes and describes hypotheses about clinical changes, but the displayed results do not contain outcome estimates or analyses. The statistical analysis plan, analysis populations, missing-data methods, multiplicity approach, and sample-size justification are not reported in the registry record. The record does not identify which parties were masked or describe allocation concealment.

Intervention descriptions are also uneven in detail. The record names social intervention and management of metabolic and vascular risk factors, while the arm description gives more detail about progressive resistance training and cognitive stimulation. It does not report delivery details for every component. This limits understanding of the exact intervention participants received, without establishing that any component was omitted.

For safety, the registry lists zero serious and other adverse events and zero deaths in both groups, but provides no event definitions, exposure-time detail, or uncertainty estimates. These limitations concern what can be inferred from the posted record; they do not establish that unreported outcomes or procedures were absent from the study.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Multidomain Intervention Program for Older People With Dementia — NCT04948450.
• Registry record last updated 2025-04-06; status last verified 2025-03.
• Results first posted 2025-04-06.
• 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

This completed, randomized, parallel-group pilot study concerns a multidomain intervention for older people with dementia in nursing homes. The registry lists enrollment of 60, triple masking, and a 6 months primary outcome timeframe. The program includes physical activity, cognitive stimulation, social intervention, and management of metabolic and vascular risk factors; the control group received general health advice.

The primary endpoint is adherence, defined as the percentage of planned sessions attended and assessed only in the intervention group. The posted value is 85.4% for 30 participants. The registry does not post a comparative adherence estimate, clinical outcome analyses, or uncertainty estimates for the primary result. It lists 14 secondary outcomes posted and 16 outcome measures overall, with no analyses listed in the displayed results. Serious adverse events, other adverse events, and deaths are each reported as 0 in both groups, with 30 participants at risk per group. Further details on analysis methods, missing data, and the interpretation of these results are not reported in the registry record.