Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment (NCT03292705), a randomized na study. The primary outcome is Mean Change in ADL Score From Baseline to Week 10.

2. Clinical Question

3. Trial Design

The registry identifies this as a randomized, single-masked, parallel-group trial, with phase listed as NA and status listed as completed. The trial title concerns applying a person-centered approach to cognitive training among senior living community residents with mild cognitive impairment. Enrollment was 49. The trial start date was 2017-10-01, and primary completion was 2019-04-05. The sponsor was the University of Rochester.

The two named groups were PEP+CCI and Control+CCI. The PEP description centers on using personalized computer-led activities to engage participants with tablet computers, followed by cognitive training. The control description states that an inert condition was used for the first 4 weeks and CCI for 6 more weeks. The record does not fully specify the PEP schedule, how CCI was administered, the frequency or duration of sessions, or the details of the single masking procedure. Who was masked is not reported in the registry record.

The posted primary endpoint summaries include 21.0 participants in each group. The registry enrollment figure and the endpoint group counts describe different aspects of the record; the reason for the difference is not reported in the registry record. The analysis population, participant flow, reasons for missing endpoint data, and any exclusions from analysis are not reported in the registry record. Random allocation is recorded, but the allocation sequence method and concealment procedures are not reported in the registry record.

The trial also posted secondary outcomes involving attitudes toward computers, visuospatial memory, and EPCCE scores. The registry record does not report the protocol’s planned sample-size justification, its original design assumptions, or a detailed statistical analysis plan. Those omissions limit assessment of how the posted outcome summaries relate to the original design and prespecified analysis.

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: 83 people were accessed to eligibility; 3 were not interested and 31 did not meet inclusion criteria.

End of 4 week evaluation

Reasons for not completing this period:

End of week 10 evaluation

Reasons for not completing this period:

End of 23 weeks

Reasons for not completing this period:

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 Mean Change in ADL Score From Baseline to Week 10, measured over Baseline to Week 10.

The primary endpoint is mean change in Activities of Daily Living (ADL) score from baseline to Week 10. The ADL score is the sum of 15 items and ranges from 0 to 60. Lower scores indicate better self-perceived functioning in daily living activities, while higher scores indicate more impaired functioning. Change is defined as the Week 10 score minus the baseline score, so a positive change indicates a movement toward a higher score and a negative change toward a lower score.

ADL is relevant to this trial because its stated aim concerns cognitive and functional health, and daily functioning is a distinct outcome from a test of cognition or an attitude toward technology. A change score summarizes the average within-person difference between the two measurement occasions, then the group means can be compared. It does not show how many individuals improved or worsened, nor does it describe the distribution of individual changes. Those participant-level details are not reported in the registry record.

The endpoint is self-perceived functioning according to the record’s description. It should therefore be interpreted as a score-based measure, not as a direct count of independently observed functional abilities. The record does not report information about the ADL instrument’s validation in this population, scoring procedures beyond the stated sum and range, or how missing responses were handled.

7. Results Posted in the Registry

• PEP+CCI: mean 0.00 versus -0.29 on control; difference 0.29 (95% CI -1.52 to 2.10), standardized effect d = 0.10; z-test p = 0.754.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Mean Change in Attitudes Toward Computers Questionnaire

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • PEP+CCI: mean 0.05 versus 0.33 on control; difference -0.28 (95% CI -3.75 to 3.19), standardized effect d = -0.05; z-test p = 0.874.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PEP+CCI and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change in Brief Visuospatial Memory Test

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • PEP+CCI: mean 0.50 versus 2.76 on control; difference -2.26 (95% CI -3.93 to -0.59), standardized effect d = -0.78; z-test p = 0.008.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for PEP+CCI than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Mean Change in EPCCE Sum Score From Baseline to Week 4

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • PEP+CCI: mean -0.55 versus -1.00 on control; difference 0.45 (95% CI -0.66 to 1.56), standardized effect d = 0.23; z-test p = 0.426.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PEP+CCI and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the focus beyond daily functioning. They include attitudes toward computers, Brief Visuospatial Memory Test scores, and EPCCE sum scores. These measures relate to the study’s person-centered rationale and cognitive-training context, but they do not measure the same construct as ADL. An attitude measure can reflect participants’ views of computers, a memory measure addresses a cognitive domain, and EPCCE is reported as a sum score; the expansion and interpretation of EPCCE are not reported in the registry record.

Across the secondary results with detailed group summaries, the pattern is not uniform. The attitudes comparison is close to no mean difference and has a wide interval. The visuospatial memory comparison favors a higher mean change in the control group under the reported contrast, while the EPCCE comparison is modest and uncertain. Scale direction and thresholds for meaningful change are not reported for these measures, so the estimates should not be translated into claims about benefit or harm. No additional endpoint-specific interpretation is needed to understand the broad pattern: the secondary comparisons do not form a consistent counterpart to the primary ADL result.

The secondary measures are related to the trial’s stated aims but cannot substitute for the primary endpoint. A result on attitudes or memory does not establish a difference in self-perceived daily functioning, and a primary ADL comparison does not settle whether attitudes or cognition changed. The registry lists secondary assessments at different time points, including Week 4 and Week 10 for EPCCE; comparisons at different times answer different questions and should not be collapsed into a single conclusion.

Unadjusted secondary results carry less weight because many outcomes and time points create multiple opportunities for an apparently notable result. The registry record does not report a multiplicity adjustment or a hierarchical testing plan. Consequently, a nominal p-value should be treated as exploratory rather than as confirmatory evidence on its own. The registry reports 12 secondary outcomes, while the details available for interpretation include only a subset of outcome summaries. The remaining detailed estimates and any combined interpretation are not reported in the registry record.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Mean Change in Attitudes Toward Computers Questionnaire
• Mean Change in Attitudes Toward Computers Questionnaire
• Mean Change in Attitudes Toward Computers Questionnaire
• Mean Change in Brief Visuospatial Memory Test
• Mean Change in Brief Visuospatial Memory Test
• Mean Change in Brief Visuospatial Memory Test
• Mean Change in EPCCE Sum Score From Baseline to Week 4
• Mean Change in EPCCE Sum Score From Baseline to Week 10

9. Statistical Interpretation

10. Statistical Methods Explained

Mean change is a continuous-outcome summary. For each group, the posted value represents the average of participants’ Week 10 ADL scores minus their baseline scores. The standard deviation describes variation among the participant-level change scores around the group mean. It is not the standard error of the mean and does not describe the uncertainty in the group average by itself. The registry record does not report participant-level observations, so the distribution of changes and the influence of unusually large changes cannot be assessed from these summaries.

What does the mean difference represent?

The comparison is a difference between group means: the PEP+CCI mean change compared with the Control+CCI mean change. The posted estimate is 0.29. A value of zero would correspond to equal mean changes. Positive or negative values indicate the direction of the contrast under the reported ordering, but their substantive meaning depends on the score direction. Because lower ADL scores indicate better self-perceived functioning, a positive change is not automatically a favorable result. The comparison estimates a group-level difference; it does not report the proportion of participants who improved, remained stable, or worsened.

The arm summaries give the group means and standard deviations, while the comparison also gives an interval and an unadjusted p-value. The posted group means are 0.0 for PEP+CCI and -0.29 for Control+CCI, with standard deviations of 2.28 and 3.57, respectively. The record includes 21.0 participants for each primary endpoint group summary. These quantities allow a simple unadjusted comparison, but do not reveal how the trial handled baseline covariates or incomplete observations.

How should the p-value be read?

The unadjusted p-value is 0.754. In general, a p-value measures how unusual a result at least as extreme as the observed one would be under a specified null model. It is not the probability that the null hypothesis is true, nor the probability that the result occurred by chance in a general sense. Its interpretation depends on the model and analysis procedure. The registry record does not report a detailed model for the primary endpoint or a prespecified testing threshold for the primary analysis. The p-value should therefore be understood as an unadjusted summary associated with the posted comparison, not as a complete account of the trial’s analysis plan.

A large p-value does not establish that the groups are equivalent. Equivalence requires a prespecified margin and an analysis designed to assess whether the plausible differences fall within that margin. Such a margin and analysis are not reported in the registry record. In this trial, the interval is also important because it shows that the estimate is not sufficiently precise to isolate a narrow set of plausible values.

What role does the standard deviation play?

Standard deviations quantify the spread of individual change scores within each group. Greater spread means participants’ changes were more variable around their group average. The primary group standard deviations were 2.28 and 3.57. The comparison’s pooled standard deviation is 2.995, a combined variability summary used in the simple standardized effect calculation. The standardized effect listed for the primary comparison is 0.097. Such a standardized summary expresses the contrast relative to variability, but it does not replace the original score scale or establish clinical importance.

Over-dispersion is a general issue when observed variability is greater than a model assumes. In general, if an analysis understates variability, its uncertainty can appear too small and its interval too narrow. The registry record does not report an over-dispersion assessment or an alternative variance model for this continuous endpoint. The posted standard deviations allow a basic description of observed spread but do not by themselves establish whether a model assumption was satisfied.

What is and is not known about the analysis?

The registry record reports no analyses for the primary outcome and no reported analyses for the secondary outcomes represented in the posted details. The comparison summaries are unadjusted recalculations based on group-level statistics. A recalculation can help readers understand the contrast, but it cannot reproduce an analysis that might depend on individual participant data, covariates, repeated-measures structure, or a specific missing-data method. Whether any such methods were used is not reported in the registry record.

The record identifies random allocation, but does not report the allocation procedure, analysis population, handling of missing observations, or whether the analysis followed intention-to-treat principles. It also does not report whether there were interim analyses, how outcomes were selected for reporting, or whether any covariate adjustment was prespecified. These unknowns should remain unknown rather than being inferred from common practice. The group summaries support a descriptive comparison; they do not supply the full statistical model or its assumptions.

11. Confidence Intervals and Precision

The primary mean difference is 0.29, with an interval from -1.522 to 2.102. A confidence interval is generally a range of estimates compatible with the observed data and the statistical procedure used, under its assumptions. It is not a guarantee that the true value lies within the interval, and it is not a range containing a specified proportion of individual participants’ changes. The confidence level for the posted interval is not reported in the registry record.

The interval includes zero, so the posted summaries do not isolate a direction of difference between the groups. Values below zero and above zero remain compatible with the interval. The width also indicates limited precision: the observed estimate alone should not be treated as a precise measure of the underlying group difference. Since no clinically important ADL difference is reported, the interval cannot be classified as excluding or including a clinically meaningful threshold.

The group standard deviations, 2.28 for PEP+CCI and 3.57 for Control+CCI, describe variability in change scores. They are not confidence limits. Likewise, the standard errors listed for the groups, 0.497 and 0.779, describe uncertainty in their respective means and should not be confused with the participant-level spread. Interpretation of any interval depends on the analysis assumptions, which are not fully reported for this outcome.

The registry record does not report a prespecified equivalence margin, a noninferiority margin, or a clinically important difference for ADL. Thus, the interval should be read as a statement of statistical precision rather than a clinical verdict. It leaves uncertainty about the magnitude and direction of the group contrast, and the posted results do not resolve that uncertainty.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. They are illustrations based on the observed effect, not the trial’s own design calculation. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. The original trial’s sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the number of participants per arm that the planning calculation estimates would be needed for an 80% chance of detecting the specified effect under those assumptions, if that effect and model were correct. The 90% power column uses a higher target chance of detection and therefore calls for more participants per arm. These figures describe hypothetical future planning, not what happened in this trial.

Each planning row uses a different fraction of the observed effect: 100%, 75%, or 50%. A smaller effect is harder to distinguish from random variation at the same significance level, so the calculation requires more participants per arm. This relationship is visible in the ADL planning figures: for the full observed effect, the estimate is 1,675 participants per arm for 80% power and 2,242 for 90% power; planning for 75% of the observed effect gives 2,978 and 3,986, while planning for 50% gives 6,699 and 8,968. The large figures reflect the very small observed standardized difference, not a guarantee about what a future trial would need.

This is not observed power. It is a prospective illustration calculated from the observed effect and stated assumptions. It should not be used to reinterpret the trial’s results as though the trial had been designed or analyzed under those assumptions.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.290; pooled standard deviation σ = 2.995.
2. n = 2 × (1.96 + 0.842)² × 2.995² / 0.290² = 1,674.6, rounded up to 1,675 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.29                      # observed difference in means
sigma <- 2.99527127319046                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3292705)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 1,675 (80% power), 2,242 (90% power)
 75% of observed effect: n per arm = 2,978 (80% power), 3,986 (90% power)
 50% of observed effect: n per arm = 6,699 (80% power), 8,968 (90% power)
power.t.test: 1675.6 
Simulated power at n = 1,675 per arm: 0.801 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study evaluates several outcomes, time points, or contrasts. Even if each individual comparison is conducted appropriately, a larger collection of tests increases the chance that at least one result will look unusual by chance. The registry record lists multiple secondary outcomes and repeated assessments, so the secondary p-values require cautious interpretation. No correction for multiplicity, prespecified outcome hierarchy, or strategy for distinguishing confirmatory from exploratory analyses is reported in the registry record.

The record does not report a detailed statistical analysis plan. It is therefore unknown whether the primary endpoint was analyzed using a particular covariate-adjusted model, whether any secondary analyses were prespecified, or how the investigators planned to handle multiple tests. The posted comparisons are unadjusted recalculations from summary statistics. They should not be mistaken for a full account of any analysis conducted by the sponsor.

Missing data are another important uncertainty. The primary endpoint summaries list 21.0 participants in each group, while the trial enrollment figure is 49. Secondary outcome summaries include different group counts, such as 22.0 and 24.0 for some assessments. The reasons for differences in available outcome counts, whether observations were missing, and how missing values were handled are not reported in the registry record. No imputation method, sensitivity analysis, or missingness assumption is reported.

The analysis population is also not reported in the registry record. The record does not state whether participants were analyzed according to their randomized group, whether any participants were excluded after allocation, or whether the endpoint summaries use all randomized participants with available measurements. Without those details, the posted means can be described as outcome summaries, but their relationship to an intention-to-treat or other analysis population cannot be established.

These omissions do not invalidate the descriptive statistics, but they constrain inference. If missing outcomes or analysis exclusions were related to participants’ health, engagement, or outcome values, the observed summaries might not represent the randomized groups in the same way. The record does not provide evidence to determine whether that occurred. Conclusions should therefore stay close to the reported group summaries and their uncertainty, without assuming a particular missing-data or multiplicity procedure.

15. 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 5% reporting threshold.

The registry reports serious adverse event counts of 0 in PEP+CCI and 0 in Control+CCI. The corresponding serious-event populations at risk are 24 and 25. Other adverse event counts are also reported as 0 in both groups, with populations at risk of 24 and 25. These figures are event summaries, not estimates of comparative risk adjusted for follow-up time or participant characteristics. The registry record does not report event descriptions for these categories.

The death count is 0 for PEP+CCI and 1 for Control+CCI. The record does not provide the cause, timing, relationship to an intervention, or further circumstances for the death. It should not be assumed that an event was caused by or unrelated to either intervention on the basis of these counts alone.

The adverse-event populations at risk differ from the primary endpoint group counts. The record does not explain the difference or report additional details about monitoring and ascertainment. Zero reported events in a category means none were recorded in that category for the stated group; it does not establish that no adverse experiences occurred outside the registry’s reported definitions or collection process. The safety summaries are descriptive and should not be read as a definitive comparison of safety.

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

The primary result describes an average difference in change in self-perceived daily functioning between the two randomized groups. The point estimate is 0.29, and the interval from -1.522 to 2.102 includes values both below and above zero. The posted summaries therefore leave substantial uncertainty about the direction and magnitude of the underlying difference. They do not establish equivalence, and they do not establish that either group’s intervention improved or worsened functioning.

The trial’s structure is relevant to the interpretation. Both groups received CCI, while the intervention group also received PEP and the control group had an inert condition for the first 4 weeks. The group comparison therefore addresses the contrast between those assigned approaches as described, rather than CCI versus no CCI over the whole study. The registry record does not fully report the PEP schedule or the detailed implementation of CCI, which limits interpretation of exactly what exposure the comparison represents.

The primary endpoint is a self-perceived ADL score, not a direct measure of every aspect of cognition, independence, or quality of life. The secondary outcomes address other constructs and time points. A result on one measure should not be generalized automatically to all these domains. The record does not report a clinically meaningful ADL threshold, so it is not possible to say whether the interval includes differences that participants would regard as important.

Small group summaries and incomplete reporting of analysis methods make precision and representativeness important concerns. The registry does not report the primary analysis population, missing-data handling, or adjustment for baseline differences. Although allocation is recorded as randomized, randomization alone does not resolve uncertainty caused by missing outcome information or by an unreported analysis procedure.

These results are best understood as a limited estimate from a completed trial, not a final answer about personalized engagement or cognitive training. They can inform the design of future studies by highlighting the need to specify outcomes, analysis methods, missing-data procedures, and the intended size of effects. They do not provide medical advice or establish a treatment recommendation.

17. Why This Trial Matters Statistically

This trial raises a statistical question that is easy to overlook: a person-centered intervention may first affect engagement or attitudes, while the primary endpoint concerns daily functioning. Those outcomes sit at different points in a proposed pathway and should not be treated as interchangeable evidence. The posted results make the distinction visible by pairing a functional primary endpoint with secondary measures of attitudes, memory, and EPCCE scores.

The primary comparison also illustrates why a point estimate and its precision should be considered together. The mean difference is 0.29, but the interval extends from -1.522 to 2.102. A single estimate can appear concrete, yet the interval indicates that the data do not tightly pin down the contrast. A non-small p-value does not show that two approaches are identical; nor can a nominal finding on a secondary measure settle the primary functional question.

Planning calculations based on a very small observed difference can yield large required group sizes, especially when planning for smaller fractions of that effect. Such calculations are useful for understanding the relationship among effect size, uncertainty, and sample size, but they are not a substitute for the trial’s original design rationale. That rationale is not reported in the registry record. Keeping planning illustrations separate from observed outcomes prevents a common misreading of power calculations.

The record also highlights the value of transparent analysis reporting. The allocation is identified as randomized, but analysis populations, missing-data procedures, multiplicity handling, and details of the masking procedure are not reported. Those details matter because they affect how group summaries should be interpreted and how much confidence to place in secondary findings. Statistical interpretation is strongest when estimates, uncertainty, and the methods that generated them can be evaluated together.

18. 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 endpoint summaries are aggregate rather than participant-level. They do not show the distribution of ADL changes, how many participants moved in either direction, or whether a small number of values influenced the means. The standard deviations describe spread, but cannot reveal the shape of that spread or identify outliers.

The primary comparison is an unadjusted recalculation from the posted summaries. The registry record reports no primary comparative analysis, so it is not possible to evaluate a sponsor-reported adjusted estimate or compare the recalculation with the trial’s prespecified model. Covariate adjustment, baseline comparability, missing-data handling, and analysis population are not reported in the registry record.

Important operational details are also unavailable. Although single masking is recorded, who was masked is not reported in the registry record. The allocation sequence and concealment, PEP schedule, CCI delivery details, adherence, and fidelity are not fully described. These gaps make it difficult to assess how consistently the assigned conditions were implemented or whether expectations could have influenced a self-perceived endpoint.

The ADL scale’s range and direction are reported, but a clinically important difference threshold and validation details for this population are not reported in the registry record. The secondary measure scales likewise lack interpretation thresholds in the posted details. As a result, statistical differences cannot be mapped reliably to practical importance from the record alone.

Multiplicity adjustment is not reported despite multiple secondary outcomes and time points. Detailed result summaries are available for only a subset of the posted secondary outcomes, and the reason for different endpoint group counts is not reported. These limitations argue for a cautious, descriptive reading of the results rather than broad conclusions about cognitive or functional outcomes.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Applying a Person-Centered Approach to Enhance Cognitive Training in Senior Living Community Residents With Mild Cognitive Impairment — NCT03292705.
• Registry record last updated 2026-02-20; status last verified 2026-02.
• Results first posted 2026-02-20.
• 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.

22. Record Summary

NCT03292705 is a completed randomized, single-masked, parallel-group trial sponsored by the University of Rochester. It enrolled 49 participants and compared PEP+CCI with Control+CCI among senior living residents with mild cognitive impairment. The primary outcome was mean change in ADL score from baseline to Week 10, with lower ADL scores indicating better self-perceived functioning.

The posted primary means were 0.0 for PEP+CCI and -0.29 for Control+CCI. The unadjusted mean difference was 0.29, with an interval from -1.522 to 2.102 and p = 0.754. The estimate is imprecise and does not establish a difference or equivalence. The record does not report the original sample-size justification, primary analysis population, missing-data methods, or multiplicity plan. Secondary outcomes address attitudes toward computers, visuospatial memory, and EPCCE scores, but should be interpreted cautiously alongside the primary functional result.