This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Maintaining Autonomy as we Age. Strategy Training for Age-related Executive Dysfunction. (NCT01163279), a randomized na study. The primary outcome is Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01163279 |
| Phase | NA |
| Condition | Aging |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Baycrest |
| Results posted | Yes |
2. Clinical Question
Population
Healthy older adults with self-reported cognitive difficulties. The intention-to-treat population is described as all randomized participants (n=19); age limits and further eligibility details are not reported in the registry record.
Intervention
A behavioral strategy-training approach intended to address age-related executive dysfunction. The intervention is named Real world strategy approach, and the corresponding trial arm is named Cognitive Training.
Comparator
Psychosocial Education, a behavioral control intervention. The registry record does not give further detail about its content or intensity.
Primary question
Whether strategy training was associated with greater improvement in untrained everyday-life goals than psychosocial education, assessed immediately after intervention and at the later assessment. The registry record does not report a single numerical comparison that answers this question.
The primary outcome concerns goals identified by participants through the Canadian Occupational Performance Measure (COPM). A goal is considered improved to criterion when its COPM rating increases by 2 or more points. The registered unit is the percentage of untrained goals improved, although the outcome title refers to a total number of goals improved. That difference in wording makes it important to consult the measure definition when interpreting any reported result.
The stated assessment times are immediately post intervention (2 months) and 3 months later. The registry record does not provide a separate effect estimate for either time point, nor does it state how results across time points were intended to be combined. It therefore describes the clinical question and measurement framework, but does not establish the size or direction of a treatment-group difference.
3. Trial Design
This was a randomized, double-masked, parallel-group behavioral trial. The registry lists an enrollment of 19 and a completed status. Its phase is listed as NA. The study concerned aging and compared the Real world strategy approach with Psychosocial Education; the corresponding arms are named Cognitive Training and Psychosocial Education.
The record dates the study start to 2010-08 and primary completion to 2011-10. It describes an intention-to-treat analysis in which the analysis population includes all participants who were randomized (n=19). It does not provide the number analyzed at each outcome assessment or report participant flow after randomization.
Randomized allocation means that assignment was determined by a chance-based process, but the method used to generate or conceal the allocation is not reported in the registry record. The record identifies the study as double-masked but does not say who was masked or how masking was maintained. It also does not describe intervention delivery, adherence, or whether participants and staff could distinguish the behavioral programs.
The parallel model means the trial compared groups assigned to separate interventions rather than describing a crossover between them. Further details about the protocol, recruitment procedures, intervention schedule beyond the stated primary outcome timing, and sample-size justification are not reported in the registry record. The registry entries identify the design and the comparison, but do not permit a fuller reconstruction of trial conduct.
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: A total of 96 participants were assessed for study eligibility. 60 participants were excluded after a phone screening interview and 17 were excluded after a more detailed baseline assessment which included cognitive paper and pencil tasks. The remaining 19 participants were randomized to either the experimental arm or the control arm.
Overall Study
| Stage | Cogntive Training | Psychosocial Education |
|---|---|---|
| STARTED | 10 | 9 |
| COMPLETED | 8 | 9 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | Cogntive Training | Psychosocial Education |
|---|---|---|
| Withdrawal by Subject | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
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.
| Characteristic | Unit | Cognitive Training | Psychosocial Education | Total |
|---|---|---|---|---|
| Participants analysed | 10 | 9 | 19 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 10 | 9 | 19 |
| Age, Continuous | years | 74.10 (SD 8.77) | 73.67 (SD 5.43) | 73.94 (SD 7.18) |
| Sex: Female, Male: Female | Participants | 9 | 7 | 16 |
| Sex: Female, Male: Male | Participants | 1 | 2 | 3 |
| Region of Enrollment: Canada | participants | 10 | 9 | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM), measured over Immediately post intervention (2 months) and 3 months later.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of untrained goals improved |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM). The registered unit is percentage of untrained goals improved. COPM is described as a standardized semi-structured interview in which participants identify goals related to everyday life activities. A goal meets the improvement criterion if its COPM rating increases by 2 or more points.
This type of measure is intended to connect performance to activities that participants themselves identify as relevant. Focusing on untrained goals also distinguishes the outcome from direct practice on a goal during strategy training. The endpoint therefore concerns transfer to everyday activities, rather than only performance on a practiced task. That rationale is general; it does not establish that improvement occurred in this trial.
The outcome title and unit use different forms of description: one refers to a total number, while the other specifies a percentage. The registry record does not explain how the percentage was calculated or give the denominator used. It also does not supply the group-level values, an effect estimate, or uncertainty for the primary endpoint. Assessments were scheduled immediately post intervention (2 months) and 3 months later, but the record does not present separate numerical results for those times.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and a relevant functional outcome, but it does not provide a single numerical primary-outcome comparison. The primary outcome has several categories or time points and is not reduced to one comparison in the record. Without group-level outcome values or an effect estimate, the direction and magnitude of any difference between Cognitive Training and Psychosocial Education cannot be determined from the registry information.
Precision also cannot be assessed. No confidence interval, standard error, or other measure of uncertainty for the primary outcome is reported in the registry record. A confidence interval, as a general statistical concept, describes a range of effect values compatible with the data and analysis; without one, readers cannot judge how narrowly or broadly the effect was estimated. No primary-outcome p-value is reported either. Even if a p-value were available, it would not by itself describe the size or practical relevance of an effect.
The record states that the analysis population included all randomized participants (n=19). That intention-to-treat description identifies the intended population for analysis, but it does not supply the outcome data, explain how missing observations were handled, or show whether every randomized participant contributed to every assessment. The safety figures are separate from the primary efficacy outcome and cannot fill that gap.
The record lists 11 outcome measures and 18 analyses. Those counts indicate that multiple outcomes or analyses were registered, but do not show which comparisons were emphasized, whether multiplicity was addressed, or what results were obtained. No adjustment strategy or prespecified hierarchy is reported in the registry record. Caution is therefore needed in interpreting any isolated finding without knowing how it fits within the full analysis plan.
In short, the record supports describing the trial design, outcome definition, and assessment schedule. It does not support a conclusion about whether the strategy-training group had greater improvement, how large any difference was, or how precisely it was estimated. Those questions require numerical outcome results and the analysis details, which are not reported in the registry record.
9. Statistical Methods Explained
Randomization is a general design method for assigning participants to interventions by chance. It aims to reduce systematic differences between groups at the start of a trial, on average. The registry identifies this study as randomized, but the sequence-generation and allocation-concealment procedures are not reported in the registry record. The label alone does not establish how those procedures were implemented.
What does double-masked mean?
Masking is intended to limit the influence of knowledge about group assignment on trial conduct or assessment. This trial is identified as double-masked, but the record does not state which people were masked or how masking was maintained. For behavioral interventions, participants may be aware of what activities they receive; the record does not explain how masking applied in this study, so no more specific interpretation is warranted.
What does intention-to-treat describe?
The record says the analysis population includes all participants who were randomized (n=19). In general, intention-to-treat analysis aims to retain participants in their randomized groups, regardless of intervention adherence. This approach preserves the comparison created by randomization more directly than an analysis restricted to those who completed treatment. The registry statement does not, by itself, show how missing outcome measurements were handled or confirm the number contributing to each analysis.
How should the COPM endpoint be understood?
The COPM interview asks participants to identify everyday-life goals. The registered criterion defines an improved goal as one with an increase of 2 or more points on COPM ratings. The endpoint is described using both a title about a total number of goals and a unit of percentage of untrained goals improved. In general, a count and a percentage have different denominators and interpretations; the record does not explain the calculation connecting these descriptions. The primary assessments were scheduled immediately post intervention (2 months) and 3 months later. Repeated assessments can be analyzed in several ways, such as by time-specific comparisons or by a model that accounts for within-participant correlation. Those are general options, not methods identified as used in this trial.
What can be inferred about the statistical analysis?
The registry gives counts of 11 outcome measures and 18 analyses, but does not report the statistical tests, model specifications, covariate adjustments, or decision rules. It also does not report primary-outcome group summaries, effect estimates, confidence intervals, or p-values. A confidence interval is a general way to express uncertainty around an estimated effect; a p-value is a measure derived under a specified statistical model and null hypothesis. Neither can be interpreted for this outcome from the registry information because numerical results and analysis details are absent.
When many outcomes, time points, or comparisons are examined, the chance of finding at least one apparently unusual result can increase. This is the general reason multiplicity may matter. The record does not state whether a multiplicity procedure was planned or applied, so it is not possible to judge how the 18 analyses were handled together.
What do the planning assumptions mean?
The planning illustration uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It describes detectable effects as stated fractions of the observed effect. These are planning assumptions, not evidence about the results of the trial and not a report of observed power. The actual planned sample-size justification is not reported in the registry record. A planning calculation based on an observed effect is illustrative: it depends on that effect estimate and does not establish that the original trial was designed around it.
As a general statistical point, count-like outcomes may vary more than a simple model assumes. Over-dispersion means the observed variability exceeds what a particular count model expects; if relevant, failing to account for it can make uncertainty estimates too small. The registry does not identify a count model or provide enough outcome information to assess whether over-dispersion was relevant. This is a methodological consideration, not a claim about the trial's data or analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures and 18 analyses. It does not describe a hierarchy of outcomes, identify which analyses were primary or exploratory beyond the named primary outcome, or report a multiplicity adjustment. With multiple outcomes, assessment times, and possible comparisons, multiplicity can affect how isolated statistical findings should be interpreted. In general, multiplicity procedures control or otherwise address the risk of misleading conclusions across a family of tests. Whether such procedures were used is not reported in the registry record.
The registered primary outcome covers immediate post-intervention assessment and an assessment 3 months later. The record notes that the outcome has several categories or time points and is not reduced to one comparison. It does not state whether each time was analyzed separately, whether the assessments were combined, or which comparison was designated as the main test.
The record describes an intention-to-treat population including all randomized participants (n=19), but missing-data methods are not reported in the registry record. There is no account of missing outcome observations, reasons for missingness, imputation, or sensitivity analyses. The intention-to-treat label identifies the intended analysis population; it does not establish that outcome data were complete or specify how absent measurements were treated.
Consequently, the registry description is not enough to assess the impact of missing data or multiplicity on the primary result. These uncertainties are especially important because no single numerical primary comparison or accompanying inferential result is reported.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Cognitive Training | 0 | 10 | 0.0% |
| Psychosocial Education | 0 | 9 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cognitive Training | 0 of 10 |
| Psychosocial Education | 0 of 9 |
The registry lists 0 serious adverse events among 10 participants at risk in Cognitive Training and 0 among 9 participants at risk in Psychosocial Education. It also lists 0 other adverse events among 10 participants at risk in Cognitive Training and 0 among 9 participants at risk in Psychosocial Education. These are the adverse-event figures recorded for the stated at-risk groups.
These entries should be read as counts recorded in the registry, not as proof that an intervention has no risks. The record does not provide event descriptions for serious adverse events, and no top serious adverse event terms are listed. Death counts are recorded as null for both groups; null is not the same as a reported count of 0. The registry record does not explain the meaning of the missing death entries or provide further detail about safety surveillance, event collection, or follow-up completeness.
Adverse-event counts are distinct from the COPM outcome and do not indicate whether everyday-life goals improved. The at-risk figures also should not be treated as a substitute for participant-flow information or for the intention-to-treat analysis population. The safety data are limited to the entries recorded in the registry and do not establish the absence of unrecorded events.
12. What the Result Does, and Does Not, Mean
The trial addresses whether a behavioral strategy-training approach might be associated with improvement in everyday activities among healthy older adults reporting cognitive difficulties. Its use of participant-identified COPM goals gives the primary endpoint a functional focus, and the scheduled assessments cover the immediate post-intervention period and a later time point. The randomized, double-masked, parallel design is relevant context for evaluating such a comparison.
However, the registry record does not report a numerical primary-outcome result or reduce the multiple categories or time points to a single comparison. It therefore does not establish whether the groups differed, which group had greater improvement, or whether any observed difference was small or large. It also does not provide a confidence interval or other precision measure. No conclusion about the benefit or lack of benefit of either intervention follows from the design description alone.
The endpoint definition identifies a threshold of 2 or more points on COPM ratings for a goal to count as improved. That threshold explains how criterion improvement is defined; it is not evidence that any participant achieved it. The outcome title and its registered unit also differ in wording, and the record does not explain the calculation used for the percentage of untrained goals improved.
The listed 0 serious and 0 other adverse events are limited registry entries, not comprehensive proof of safety. Null death entries do not state that there were 0 deaths. More broadly, the registry does not report the statistical model, missing-data procedures, multiplicity handling, or detailed group-level results needed for an independent assessment of the primary question.
13. Why This Trial Matters Statistically
Statistically, this trial is a useful example of why design labels and outcome definitions are not substitutes for results. Randomization and masking describe features intended to support a fair comparison, while the COPM endpoint specifies a participant-centered measure and a criterion for goal improvement. Neither tells the reader what the observed group difference was or how uncertain it may be.
The endpoint raises a practical measurement issue: its title refers to a total number of goals, while its unit is expressed as a percentage of untrained goals improved. Counts and percentages answer different questions and rely on different denominators. The registry record does not reconcile that wording, so careful interpretation would require a clear definition of the analysis variable and its calculation.
The record also illustrates the importance of prespecifying how repeated time points and multiple outcomes will be interpreted. It lists 11 outcome measures and 18 analyses, but does not report how multiplicity was handled or identify a single result for the primary outcome. Without those details, an isolated analysis would be difficult to place in the context of the full set of planned or reported analyses.
Finally, the stated intention-to-treat population is informative but incomplete without participant-flow and missing-data details. For a modest enrolled group of 19, transparent reporting of outcomes, uncertainty, and analysis decisions would be important to understanding what the data can support. The registry record makes the clinical question visible, while leaving the central quantitative answer unreported.
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 central limitation for interpretation is that the registry record does not give numerical results for the primary endpoint. It identifies multiple categories or time points and does not reduce them to one comparison. Thus, neither the direction nor the magnitude of the primary contrast can be evaluated from the record. Group-level summaries, effect estimates, and precision measures are not reported.
The endpoint description itself has an unresolved wording difference: its title refers to a total number of goals improved to criterion, while its unit is percentage of untrained goals improved. The definition of criterion improvement is stated, but the denominator and calculation of the percentage are not reported in the registry record.
Details needed to assess potential bias and analytical robustness are also absent. The record does not specify randomization procedures, who was masked, missing-data methods, statistical models, covariate adjustment, or multiplicity handling. It describes an intention-to-treat analysis of all randomized participants (n=19), but does not give outcome-specific participant counts or participant flow.
The sample-size justification and detailed protocol are not reported in the registry record. Safety entries are limited, with death counts recorded as null and no serious-event terms listed. These limitations constrain interpretation of both efficacy and safety; they do not establish that the interventions had no effect or that no events occurred.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Maintaining Autonomy as we Age. Strategy Training for Age-related Executive Dysfunction. — NCT01163279.
- Registry record last updated 2017-12-18; status last verified 2017-11.
- Results first posted 2017-01-12.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry describes a completed randomized, double-masked, parallel behavioral trial sponsored by Baycrest, with an enrollment of 19. The study began in 2010-08 and reached primary completion in 2011-10. It compared the Real world strategy approach, listed under the Cognitive Training arm, with Psychosocial Education.
The primary outcome concerns COPM goals improved to criterion, defined as a rating increase of 2 or more points, with assessments immediately post intervention (2 months) and 3 months later. The analysis population is described as all randomized participants (n=19). The record lists 11 outcome measures and 18 analyses, but does not report a single numerical primary comparison, its uncertainty, or details of the statistical analysis and missing-data handling.
Adverse-event entries report 0 serious and 0 other events in each listed at-risk group; death counts are null. The registry record identifies the study question and design, but does not provide enough outcome information to determine the primary effect or its precision.