Improving Prospective Memory Via Telehealth: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Prospective Memory Via Telehealth (NCT05129293), a randomized na study. The primary outcome is Memory for Intentions Test Total Score Percentile.

2. Clinical Question

3. Trial Design

This was a randomized, double-masked, parallel-group feasibility trial, listed as completed. The registry identifies Trinity Health Of New England as the sponsor and lists multiple sclerosis as the condition. The record gives a start date of 2021-11-01 and a primary completion date of 2023-06-05. The phase is listed as NA.

The study description specifies two behavioral groups: a prospective-memory intervention and an educational control. The intervention description says participants would meet with an interventionist twice a week for four weeks. The education group was to meet with a research assistant at the same frequency and receive psychoeducation about MS and cognitive functioning. The registry describes the study as double-masked, but does not report the masking procedures or identify which roles were masked.

The registry lists enrollment of 35. Its brief description says 18 participants would be randomized to the prospective-memory intervention and 18 to education. Those figures describe the planned group allocation in the summary; the record does not explain how they relate to the enrollment figure. The adverse-event information lists 17 participants at risk in the intervention group and 18 in the education group. These figures are safety denominators and should not be assumed to define the analysis population for the primary outcome.

The study was framed as a feasibility trial. Feasibility domains listed in the description include recruitment, enrollment, retention, treatment adherence, credibility and expectancy, and satisfaction. The record does not provide results for these domains. It also does not report the randomization procedure, allocation concealment, detailed eligibility criteria, or a statistical analysis plan.

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

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 Memory for Intentions Test Total Score Percentile, measured over Six weeks.

The primary outcome is the Memory for Intentions Test Total Score Percentile, with the registry naming six weeks as the timeframe. The MIST is described as an objective measure of prospective-memory performance. Its total score is calculated by summing raw scores from six subscales and transforming that total to a percentile using age- and education-stratified normative data. Higher scores indicate better prospective-memory performance.

A percentile expresses a person’s position relative to a reference distribution. In general, converting a raw score to a percentile can help contextualize performance against a norm group, but the interpretation depends on the suitability of those norms for the people being assessed. The registry says the norms are stratified by age and education; further details about the normative reference sample are not reported in the registry record.

The endpoint is relevant to the study’s stated focus because it measures performance on an objective prospective-memory test. The study description says the MIST would be administered at baseline and after treatment, and proposes a preliminary effect size for the group difference. The posted record does not report a single comparison of the primary endpoint, group means, standard deviations, or an effect estimate. It notes that the primary outcome has several categories or time points and was not reduced to one comparison. Therefore, the endpoint definition is available, but the registry record does not support a numerical conclusion about the between-group result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design is described as randomized, double-masked, and parallel-group. In general, randomization is intended to create groups that are comparable at the start of a study, on average, by assigning participants through a chance-based process. A parallel design means each participant is assigned to a group rather than receiving both study interventions in sequence. The registry does not report how the random sequence was generated, how assignments were concealed, or which people were masked. Those details are not reported in the registry record, so the design labels alone do not establish how these procedures were implemented.

The two groups received behavioral programs. The intervention group was assigned prospective-memory training, while the active control received education about MS and cognitive functioning. In general, an active control can help distinguish effects associated with the specific intervention from effects associated with taking part in study sessions. It does not eliminate all possible differences between groups. Here, both arms were described as meeting at the same frequency, but further details about treatment delivery, fidelity, and adherence results are not reported in the registry record.

The outcome is continuous: a percentile score from the MIST Total Score. The record identifies the mean as the parameter and standard deviation as the dispersion measure. In general, a mean describes the center of a distribution, while a standard deviation describes variation among individual measurements around that center. Neither alone gives the uncertainty of a group comparison. A standard error or confidence interval for the contrast would be needed to describe precision, and those primary-comparison results are not reported in the registry record.

The registry description proposes a preliminary Cohen’s d for the difference between groups. In general, Cohen’s d expresses a difference in means relative to a measure of variability. It can provide a standardized description of the observed contrast, but it does not by itself establish that a difference is reliable or clinically important. The value, calculation details, and uncertainty for the proposed effect size are not reported in the registry record. The posted information therefore does not permit interpretation of its magnitude.

The description identifies baseline and post-treatment MIST assessments, with the primary outcome timeframe listed as six weeks. A trial could analyze such data by comparing post-treatment scores, comparing change from baseline, or using a model that accounts for repeated measurements. These approaches answer related but not identical questions and can rely on different assumptions. The registry record does not identify which primary-outcome model or contrast was used, whether baseline values were included in an adjusted analysis, or how repeated measurements were handled. It would not be appropriate to infer one of these methods from the outcome schedule alone.

In general, confidence intervals are useful because they display both an estimated effect and its statistical uncertainty. A narrow interval indicates greater precision under the analysis assumptions; a wide interval indicates greater uncertainty. A confidence interval that includes a null value does not prove that groups are identical, and an interval excluding a null value does not alone establish clinical importance. No confidence interval for the primary comparison is reported in the registry record.

In general, the assumptions of a statistical model should be considered when interpreting an estimate. For a continuous outcome analyzed through means, relevant considerations can include the outcome distribution, influential observations, and whether variability differs between groups. If data are more variable than a model expects, uncertainty estimates can be too small unless the analysis accounts for that extra variability. These are general considerations, not descriptions of analyses performed in this trial; diagnostics and model assumptions are not reported in the registry record.

The sample-size assumptions associated with planning illustrations specify a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. They state that the effect to detect is a fraction of the observed effect. These are planning illustrations based on the observed effect, not the trial’s own design or sample-size justification. In general, such calculations explore how a future study’s required enrollment may vary with its target effect and power assumptions. They are not observed power and do not establish the probability that the trial’s findings are true. The registry record does not report the trial’s sample-size justification or a prospective power calculation.

The study description calls for a feasibility assessment as well as a preliminary effect-size calculation. These are distinct aims. Feasibility measures can describe whether study procedures were workable, while an effect estimate can help characterize a possible outcome difference. In general, estimates from a small feasibility study may be imprecise and can be unstable; their role is not automatically the same as a definitive efficacy test. The registry does not report feasibility results or the primary effect estimate, so neither can be evaluated from the posted record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and three analyses. The primary outcome description concerns the MIST Total Score Percentile, but the record notes that the primary outcome has several categories or time points and was not reduced to one comparison. It also lists the Perceived Deficits Questionnaire-Prospective Memory Subscale as a secondary outcome. The available record does not specify which analyses correspond to each outcome, how many contrasts were tested, or whether any adjustment for multiple comparisons was planned or performed.

In general, testing multiple outcomes, time points, or contrasts can increase the chance of at least one apparently unusual result when all null hypotheses are true. Methods for addressing multiplicity can include defining one primary contrast in advance, adjusting inference across a family of comparisons, or treating secondary analyses as exploratory. The record does not identify a multiplicity strategy. Without the analysis plan and the results for each contrast, the extent and handling of multiplicity cannot be assessed.

The registry description says MIST performance would be assessed at baseline and post-treatment, but it does not report missing-data counts, reasons for missingness, or the method used to handle incomplete measurements. It also does not specify whether the primary analysis included all randomized participants, only participants with observed outcomes, or another analysis population. These details are not reported in the registry record.

In general, missing-data methods rely on assumptions about why observations are absent. Different assumptions can lead to different estimates, so the number and pattern of missing observations and the chosen method are important for interpreting a result. Because the registry does not report this information or a primary numerical comparison, the influence of missing data cannot be evaluated.

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 5% reporting threshold.

The registry lists zero serious adverse events and zero other adverse events for the prospective-memory intervention group, with 17 participants at risk. It lists zero serious adverse events and zero other adverse events for the education group, with 18 participants at risk. Deaths are listed as zero in both groups. No serious adverse-event terms are listed.

These figures describe the event counts recorded in the registry, not a measure of the primary cognitive outcome. A zero count means no events of the listed type were recorded in the posted results for the corresponding group; it does not show that the underlying risk is exactly zero. In general, event counts should be interpreted alongside the number of participants observed, the duration and completeness of follow-up, and the way events were defined and collected.

The record does not report further details about adverse-event ascertainment, follow-up completeness, or the severity and timing of non-serious events. The figures therefore provide a limited account of the safety information posted in the registry and should not be read as a complete characterization of all possible harms.

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

This trial record is useful for understanding the study’s question and structure. It describes a randomized comparison of a prospective-memory intervention with an educational control in people with MS. It identifies an objective prospective-memory test as the primary outcome and describes feasibility domains that the study intended to assess. It also provides basic registry status, enrollment, and adverse-event counts.

The posted information does not establish the size or direction of a difference between groups on the MIST outcome. Although the study description says that a preliminary Cohen’s d would be computed, no such estimate is reported in the registry record. There is also no reported primary comparison, confidence interval, or p-value. As a result, the record does not support a conclusion about the comparative outcome effect or its precision.

In general, results from a feasibility study and results from a study designed to estimate an intervention effect can serve different purposes. Feasibility findings concern such matters as recruitment, retention, adherence, and acceptability. An outcome estimate describes the observed contrast, while its uncertainty depends on the data and analysis. The registry identifies feasibility aims, but does not report their results; it likewise does not report the proposed preliminary effect estimate.

The absence of a single primary-outcome comparison should not be interpreted as evidence that the groups had the same results, nor as evidence that they differed. It means that the numerical evidence needed to assess that question is not reported in the registry record. Similarly, the zero adverse-event counts are limited registry observations and do not demonstrate that risk is absent.

Any broader conclusion about effectiveness, clinical importance, or generalizability would require information beyond the posted record, including the outcome results, analysis methods, missing-data handling, and participant characteristics. No treatment recommendation follows from the information.

13. Why This Trial Matters Statistically

Feasibility trials can help assess whether study procedures and interventions can be delivered and whether a later, larger study is workable. This trial’s registry description identifies recruitment, enrollment, retention, adherence, treatment credibility and expectancy, and treatment satisfaction as feasibility domains. These are distinct from the primary cognitive outcome and can inform different questions about study conduct.

Statistically, clear reporting of the outcome contrast is important even when a study is framed as a feasibility trial. A defined comparison, effect estimate, and measure of uncertainty allow readers to distinguish the observed data from the study’s aims. The registry describes a planned preliminary Cohen’s d, but does not report that estimate or a single primary-outcome comparison. The result is that the design and endpoint can be described, while the comparative outcome cannot be quantified from the record.

The active education comparator is also important to the interpretation of the question. Both groups were described as receiving sessions, so the intended contrast is between two forms of behavioral contact, not simply between receiving an intervention and receiving none. In general, this can sharpen the question about the intervention’s specific contribution, while still leaving implementation and masking details relevant to interpretation.

The registry’s planning assumptions illustrate another statistical distinction: a calculation based on an observed effect is not the same as an enrollment justification established before a trial begins. Planning illustrations can help explore future study requirements, but they should not be mistaken for observed power or treated as evidence that the current study was adequately powered for a definitive effect test. The registry does not report its own sample-size justification.

For clinical researchers and biostatisticians, the record therefore highlights both the value of a focused feasibility question and the importance of complete outcome reporting. Without a reported contrast, uncertainty estimate, and analysis description, the study’s potential contribution to estimating the intervention’s effect remains unclear.

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 registry record gives limited detail about the population. It identifies multiple sclerosis as the condition but does not report detailed eligibility criteria, participant characteristics, disease or cognitive profiles, or the analyzed population. These omissions constrain assessment of how well the enrolled participants represent the people to whom the research question might apply.

The intervention description is incomplete. It reports the session frequency and duration, and identifies visual imagery and implementation intentions as topics in the intervention. The description ends before providing full details. The education arm is described as psychoeducation about MS and cognitive functioning, but the registry does not report fidelity assessments or whether participants adhered to the intended sessions.

The registry labels the study double-masked but does not describe who was masked or how masking was maintained. It also does not report the randomization sequence method or allocation concealment. These details are relevant to judging possible bias, but their absence does not establish that the procedures were inadequate.

The primary outcome is defined, but the record does not provide one numerical group comparison. It does not report the proposed preliminary effect size, group summaries, uncertainty interval, or p-value. The record also does not explain the relationship between the enrollment figure and the planned group counts in the brief description. Safety denominators are listed, but the record does not identify the analysis population for the primary outcome.

Finally, analysis details are not reported: the model and contrast, any baseline adjustment, missing-data procedures, multiplicity approach, and analysis populations are unspecified. The registry lists three outcome measures and three analyses but does not map these to a complete results presentation. Together, these limitations prevent assessment of the primary effect’s magnitude and precision and restrict interpretation of the feasibility aims.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Improving Prospective Memory Via Telehealth — NCT05129293.
• Registry record last updated 2024-10-18; status last verified 2024-10.
• Results first posted 2024-10-18.
• 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

NCT05129293 is listed as a completed, randomized, double-masked, parallel feasibility trial sponsored by Trinity Health Of New England. The registry gives a start date of 2021-11-01, a primary completion date of 2023-06-05, and enrollment of 35. The study compared a behavioral prospective-memory intervention with an educational behavioral control for people with multiple sclerosis.

The primary outcome was the Memory for Intentions Test Total Score Percentile, with a six-week timeframe. The study description also identifies feasibility domains and proposes a preliminary group effect size. The registry record does not report a single primary-outcome comparison or the proposed effect estimate. It lists zero serious adverse events, zero other adverse events, and zero deaths in both groups, with 17 participants at risk in the intervention group and 18 in education.

Details of the statistical analysis, missing-data handling, multiplicity, and primary analysis population are not reported in the registry record.