Dual Antiplatelet Therapy Adherence With Reminder App Usage: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Dual Antiplatelet Therapy Adherence With Reminder App Usage (NCT05071027), a randomized na study. The primary outcome is Change in Medication Adherence.

2. Clinical Question

The trial therefore addresses a practical question about whether reminders might be associated with adherence barriers in this clinical setting. The posted record does not contain adherence scores or a comparison of change between the groups. It cannot establish whether app reminders altered adherence, and it does not report a result for the primary question. The study also lists non-adherence-associated mortality, morbidity, and related adverse events as secondary outcomes; their presence in the registry does not substitute for a measured adherence result.

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. Participants were assigned on a 1:1 basis to an app medication reminder group or a non-app group. Both groups received standard care, while only the app group received dual antiplatelet medication reminders. The app is named Endovascular Neurosurgery, and the intervention is classified as other in the registry.

The study focused on patients undergoing stent-based endovascular treatment for unruptured cervical and intradural, intracranial aneurysms. The record lists the condition as unruptured cerebral aneurysm. It names Montefiore Medical Center as sponsor, lists phase as NA, and gives enrollment as 9. The study status is terminated. Its listed start date is 2021-10-27 and its primary completion date is 2024-07-22. The reason for termination is not reported in the registry record.

The primary outcome was intended to assess change in medication adherence using a medication compliance score generated by the Adherence Barrier Questionnaire. The registry specifies the procedure day, 2-4 weeks post-procedure, and 6 months post-procedure as assessment times. However, it states that data needed to obtain the score could not be collected, so the outcome could not be evaluated. No analysis is listed in the record.

In general, random assignment is intended to make assigned groups comparable on average, while a parallel design compares groups followed under their assigned approaches. Those design features do not guarantee that groups will be balanced in a small study, nor do they remedy missing outcome measurements. Because masking is listed as none, participants and study personnel were not masked according to the registry entry. Other details, including how the random sequence was generated, whether assignment was concealed, and how adherence to assigned group was handled, are not reported in the registry record.

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: 1 patient died prior to being administered the application. They were randomized into the "App Medication Reminder Group" but never received the application.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Data related to 'Change in Medication Adherence' was unable to be collected in order to obtain an Adherence Barrier Questionnaire Score and, as such, this Outcome was unable to be evaluated.

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.

Population: The remaining of the patients did not complete the follow up.

6. Primary Endpoint

The registry lists the primary outcome as Change in Medication Adherence, measured over Day of Procedure, 2-4 weeks post-procedure, 6 months post-procedure.

The primary endpoint is change in medication adherence, assessed with a medication compliance score generated by the Adherence Barrier Questionnaire. The registry describes the intended change as running from the procedure day through 6 months post-procedure, with assessments also listed at 2-4 weeks post-procedure. The score ranges from 14 to 52, and a higher score indicates that a patient faces greater barriers to medication adherence.

A questionnaire score is a way to operationalize a behavior or experience that may not be directly captured by a clinical event. In general, repeated assessments can describe how a measured construct changes over follow-up; interpreting change requires the score to be available at the relevant assessment times and a clearly specified comparison. The stated direction of this scale matters: a higher score reflects greater reported barriers, not better adherence.

The registry explicitly states that the data needed to obtain an Adherence Barrier Questionnaire Score could not be collected and that the outcome was unable to be evaluated. Consequently, there is no reported baseline score, follow-up score, change estimate, or between-group result for this endpoint. The stated scale range and direction explain what the planned measure was intended to represent; they do not supply an observed outcome. The reason the questionnaire data were unavailable is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization assigns participants to study groups using a chance-based process. In general, its purpose is to reduce systematic differences between groups at assignment, so that a comparison can be more informative about the intervention. Randomization does not ensure that every relevant characteristic is balanced, particularly in a small study. The record identifies the design as randomized and the allocation as 1:1, but the random-sequence method and any allocation-concealment procedure are not reported in the registry record.

What does a parallel, unmasked design mean?

In a parallel-group design, participants are assigned to one group and the groups are compared over the study period. Here, the registry describes an app medication reminder group and a non-app group, with standard care in both. The masking entry is none. In general, lack of masking can matter when participants know which approach they receive, particularly for outcomes based on self-report or questionnaires. That is a consideration in interpreting a planned questionnaire score, not evidence that reporting was biased in this study. Procedures to limit or assess such influence are not reported in the registry record.

What was the intended outcome comparison?

The primary endpoint was change in a medication compliance score generated by the Adherence Barrier Questionnaire. The registry says a higher score, on a scale ranging from 14 to 52, indicates greater barriers to medication adherence. It lists measurement on the procedure day, 2-4 weeks post-procedure, and 6 months post-procedure. In general, analyzing repeated measurements can involve estimating change over time within groups, comparing change between groups, or modeling all available measurements together. These approaches answer related but not identical questions; the selected estimand and model should be specified in advance. The statistical analysis plan and the precise planned contrast are not reported in the registry record.

Most importantly, the registry states that data needed to calculate the questionnaire score could not be collected, so the primary outcome could not be evaluated. Without observed endpoint values, no model or group comparison can produce an evidence-based estimate of the app's association with this outcome. The record lists no analyses. It is not possible to infer which analysis would have been used, how missing observations would have been handled, or whether changes from baseline would have been adjusted for baseline scores.

How should the planning assumptions be read?

The registry describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. In general, a significance level is a design assumption governing a test's threshold, and a normal approximation uses a mathematical distribution to simplify estimation or testing. These assumptions describe the stated planning approach; they are not reported analysis results. No resulting planning sample-size figures are stated in the record summarized by the posted results, so there is no numeric planning target to interpret.

A sample-size illustration is a planning exercise: it describes the number of participants per arm that would be needed under specified assumptions and for a specified effect. It is not a measure of the probability that the completed study detected an effect. In particular, observed power should not be inferred from the enrollment or from a planning illustration. The record does not report a sample-size justification used to design the trial, and the primary endpoint could not be evaluated. Therefore, an illustration based on an observed effect cannot be treated as evidence that the primary endpoint produced an observed effect in this trial.

Why does over-dispersion matter in general?

For outcomes that are counts, a statistical model may assume a particular relationship between the average count and its variability. Over-dispersion means the data vary more than that assumption allows. If it is ignored, standard errors can be too small and confidence intervals too narrow, making results appear more precise than they are. This is a general issue in count-data analysis; the record does not report a count model or an over-dispersion assessment for the primary endpoint. The adherence score is described as a questionnaire score, not as a count outcome.

Other key analysis choices are not reported in the registry record. These include the primary analysis population, handling of protocol deviations, treatment of missing questionnaire items, covariate adjustment, and any method for repeated measurements. They should not be inferred from the randomized design alone. The registry’s statement that the score could not be obtained is more fundamental than those modeling choices: the endpoint needed for the planned comparison was not available for evaluation.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome was specified at multiple assessment times: the procedure day, 2-4 weeks post-procedure, and 6 months post-procedure. The registry does not reduce these time points to a single reported comparison, and the endpoint itself could not be evaluated because the questionnaire score was unavailable. There is no reported test or estimate across those measurements.

Multiplicity arises in general when several outcomes, time points, groups, or analyses are tested. Repeated testing can increase the chance of a seemingly notable result arising by chance, so a statistical plan may specify a primary comparison or a method to control error across tests. The registry record does not report a multiplicity strategy, a hierarchy of outcome tests, or a prespecified primary time point for a single comparison. No correction method should be assumed.

The missing primary outcome is explicitly described: data needed to obtain the Adherence Barrier Questionnaire score could not be collected, and the outcome was unable to be evaluated. The reason for this missingness, its timing, and whether any partial questionnaire data existed are not reported in the registry record. In general, missing-data methods rely on assumptions about why values are missing; the appropriate approach cannot be identified without relevant information and an analysis plan. No imputation or other missing-data method is reported.

The registry lists no analyses, and the analysis population is not reported in the registry record. It is therefore not possible to determine whether the intended analysis would have followed randomized assignment, included only participants with measured outcomes, or used another definition. No participant-level flow or endpoint-specific analysis counts are reported. The enrollment figure alone does not show how many people had usable questionnaire data or contributed to any outcome analysis.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The posted safety figures report zero serious adverse events and zero other adverse events in the app medication reminder group, where 3 participants are listed as at risk. The non-app group has zero serious adverse events and zero other adverse events, with 6 participants listed as at risk. Deaths are reported as 0 in each group. These are the recorded counts; they should not be restated as evidence that no risk exists.

In general, an event count is most informative when read alongside the population at risk, the follow-up period, and the way events were collected and classified. The registry supplies group-specific at-risk counts but does not report further detail about event ascertainment, event timing, or the definitions used for the listed categories. The record also lists no top serious-event terms.

Zero recorded events in a small study can coexist with uncertainty about the frequency of uncommon outcomes. The counts do not establish equivalence between groups, nor do they demonstrate that either approach prevents events. They are descriptive safety information and do not replace the unavailable primary adherence outcome. The registry’s secondary outcome titles concern mortality, morbidity, and related adverse events associated with dual antiplatelet non-adherence; the recorded event counts alone do not establish such an association.

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

The result that can be read from this record is primarily about outcome availability: the study planned to assess medication adherence with a questionnaire-derived score, but the required data could not be collected and the outcome was not evaluated. No estimate of change and no comparison between reminder-app and non-app groups are reported. Accordingly, the record does not show whether medication reminders changed questionnaire-measured barriers to adherence.

This is not the same as finding no effect. A null or inconclusive estimate would still require observed outcome data and an analysis; neither is reported for the primary endpoint. Nor can the randomized design alone answer the question. Randomization is a design feature, while a treatment comparison depends on measured outcomes and an appropriate analysis.

The record does describe the study’s allocation, groups, intended assessments, enrollment, status, and event counts. Those details help clarify what investigators planned and what was recorded, but they do not fill in missing adherence scores. The safety counts are descriptive and should not be taken as evidence that adverse-event risk is absent or that the groups are equivalent.

The practical scope is also limited to the study population and intervention described in the registry: patients undergoing stent-based endovascular treatment for unruptured aneurysms, with app-based dual antiplatelet reminders compared with standard care without those reminders. The record does not report an evaluated primary outcome that would support conclusions about this comparison, and it does not establish a result for other populations or reminder approaches.

Thus, the most defensible reading is that the registry documents a randomized study whose intended primary endpoint could not be assessed. The reason for termination and the reason questionnaire data were unavailable are not reported in the registry record. Neither should be guessed, and neither can be inferred from the absence of an adherence result.

13. Why This Trial Matters Statistically

This trial is statistically informative in part because it illustrates the distinction between a planned question and an answerable analysis. The registry defines an adherence outcome, a score direction, assessment times, and two randomized groups. Yet it also states that data needed to calculate the score could not be collected. A clear endpoint definition cannot yield an estimate when the endpoint measurements are unavailable.

That distinction matters when interpreting trial registries. Randomization and a named primary outcome describe important design features, but they do not guarantee that a comparison can be performed. Readers need to know whether outcomes were measured, how many observations contributed, and what analysis was used. In this record, no analysis is listed and the primary endpoint was not evaluated, so effectiveness cannot be judged from the intended design alone.

The trial also underscores why precision and absence of evidence must not be conflated. In general, an estimate with a confidence interval can indicate both the direction and uncertainty of an observed comparison. Here, no primary-outcome estimate or interval is reported. It would be misleading to treat the lack of a result as a precise finding of no difference.

Finally, the safety counts offer a reminder that descriptive event totals have limits, especially in a small study. The group-specific counts are useful as a record of what was reported, but they cannot establish equivalence or rule out uncommon events. The registry’s terminated status and enrollment figure supply context, while the reasons behind termination and missing outcome data remain unreported. Together, these features make transparent reporting of outcome availability central to 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 trial-specific limitation is that the primary adherence outcome could not be evaluated. The registry says the data needed to obtain an Adherence Barrier Questionnaire Score were unable to be collected. It does not report the reason, the extent of missingness, whether data were collected at any of the planned times, or whether any questionnaire items were available. This prevents an estimate of adherence change and a comparison between the randomized groups.

The study is listed as terminated, with enrollment of 9, but the reason for termination is not reported in the registry record. The record does not explain whether termination was related to recruitment, feasibility, outcome collection, or another matter. No explanation should be inferred from the status alone. The number enrolled also does not indicate how many participants contributed to the safety counts or any specific assessment beyond the at-risk figures separately reported.

The registry lists no analyses. It does not report the primary analysis population, a statistical analysis plan, the method for handling missing data, the method for repeated assessments, or whether any adjustment was planned. The endpoint has multiple listed assessment times, but a single primary contrast or multiplicity strategy is not reported in the registry record. These omissions limit assessment of how an eventual analysis would have addressed the intended question.

The design is unmasked, according to the registry. Because the planned endpoint is questionnaire-based, knowledge of group assignment could be relevant in general, but the record does not describe how responses were collected or whether any steps addressed potential reporting effects. The random-sequence method and allocation concealment are also not reported.

Finally, the recorded safety counts are descriptive and come with limited accompanying detail about ascertainment and follow-up. They cannot compensate for the missing adherence endpoint or establish comparative safety. These limitations concern what can be learned from the registry record, not a claim about unreported study procedures.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Dual Antiplatelet Therapy Adherence With Reminder App Usage — NCT05071027.
• Registry record last updated 2024-11-15; status last verified 2024-09.
• Results first posted 2024-11-15.
• 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

NCT05071027 is a randomized, parallel-group, unmasked study sponsored by Montefiore Medical Center. It compared dual antiplatelet reminders from the Endovascular Neurosurgery app plus standard care with standard care without app reminders in patients undergoing stent-based treatment for unruptured aneurysms. Enrollment is listed as 9, and the study status is terminated.

The primary outcome was change in medication adherence measured by an Adherence Barrier Questionnaire score, planned for the procedure day, 2-4 weeks post-procedure, and 6 months post-procedure. The registry states that the score could not be obtained and the outcome could not be evaluated. No analyses are listed. The reason for termination and the reason outcome data were unavailable are not reported in the registry record.

The registry reports zero serious events, zero other events, and zero deaths in each group. These descriptive counts do not establish absence of risk or group equivalence. No primary adherence effect can be concluded from the posted results.