Improving Hypertension Medication Adherence for Older Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Hypertension Medication Adherence for Older Adults (NCT05610059), a randomized na study. The primary outcome is Medication Adherence (MEMS Cap).

2. Clinical Question

This is a randomized, double-masked, parallel-group trial, according to the design fields in the registry. The intended comparison is between the additional medication-taking and blood-pressure-management strategies in System M and the information-only approach in System E. Both groups receive information about hypertension and medication, which makes the additional strategies the main described contrast. The registry record does not state the precise primary estimand, such as whether the principal comparison was at a particular assessment or across both timeframes. It also does not give an outcome result that would resolve that question.

3. Trial Design

The registry describes a randomized, double-masked, parallel-group trial sponsored by the University of Arizona. Its status is completed. The listed start date is 2022-11-02 and the primary completion date is 2025-03-14. The phase field is recorded as NA. The condition terms include aging, medication adherence, and hypertension.

The two named intervention groups were Blood Pressure Technology System M and Blood Pressure Technology System E. The M description includes education about high blood pressure and medications, along with strategies that can be used to take medications and manage blood pressure. The E description includes information about high blood pressure and medications. The brief summary says both groups use a blood pressure system and complete assessments at 3-months and 6-months; it also describes a mid-assessment at 3-months and a post-assessment at 6-months. The registry does not explain what was masked or how masking was maintained.

There is an enrollment inconsistency in the record. The enrollment field lists 200, while the brief summary says investigators will enroll 224 older adults and assigns 112 per group. The record does not clarify whether these figures refer to different stages or whether either is the final number enrolled or analyzed. The safety information separately lists groups of people at risk, including a group labeled Enrolled But Not Randomized/Treated. Those entries do not resolve the enrollment inconsistency.

The primary completion date and completed status do not by themselves establish that outcome data or statistical comparisons were posted. The registry lists a primary adherence outcome and secondary outcomes, but reports zero outcome analyses. Details such as the randomization procedure, allocation concealment, masking procedures, analysis population, and statistical model 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: Additional Information: The difference between the number of participants enrolled in the study and the number who started the study is because only those with hypertension medication adherence of 90% or less started the study. Data Element Definition: A 28-day adherence monitoring period after enrollment determined adherence (90% or less to receive intervention) before participant randomization.

Overall Study

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 Medication Adherence (MEMS Cap), measured over 3 months, 6 months.

The primary endpoint is Medication Adherence (MEMS Cap), expressed as a percentage. The description says a smart pill bottle cap contains digital sensors that record the date and time the cap is opened, then uploads those records to AARDEX Medication Adherence Software. The percentage represents medication taken within the correct time frame. The listed assessment timeframes are 3 months and 6 months.

This measure is intended to capture medication-taking behavior using recorded cap openings rather than relying only on a participant’s account. As a general measurement point, a recorded opening is an observable event that can serve as a proxy for medication taking, but it does not directly confirm that a dose was swallowed. The registry description does not say how missing cap records, device problems, or unusual opening patterns were handled.

Adherence is relevant to the stated trial question because the intervention includes strategies for taking medication, and the intended population includes people described as nonadherent for one hypertension medication. The outcome’s percentage scale can describe adherence as a continuous measure. The registry does not report group means, standard deviations, a comparison between groups, or an estimate of change over time. It therefore provides the measurement definition and assessment schedule, but not an outcome result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record identifies randomization, double masking, a parallel-group model, a continuous primary outcome summarized by its mean, and standard deviation as the dispersion measure. It does not report the statistical analysis plan, specific tests or models, or outcome estimates. The concepts below explain how these methods are generally interpreted; they do not describe an analysis confirmed by the registry record.

What does randomization contribute?

In general, random assignment aims to make the intervention groups comparable at the start of a trial with respect to measured and unmeasured characteristics. It does not guarantee that every characteristic will be balanced in a particular trial. The trial record says allocation was randomized, but does not describe sequence generation, allocation concealment, stratification, or other details. The registry’s enrollment discrepancy also means the listed enrollment figures should not be treated as a definitive account of the analyzed groups.

A randomized comparison is most informative when the analysis preserves the groups as assigned, according to a clearly defined analysis population. Other approaches can answer different questions, depending on adherence to assigned intervention and availability of measurements. The registry record does not identify the analysis population or explain how participants who stopped using a system, did not complete assessments, or lacked usable cap data were handled.

How should a continuous mean be read?

In general, the mean is the arithmetic average of the observed values in a group. For this endpoint, the values are percentages of medication taken within the correct timeframe. A mean can be useful for comparing average adherence, but interpretation should include the group sizes analyzed, the amount of variation, the definition of the contrast, and uncertainty around that contrast. The registry lists standard deviation as the measure of dispersion, which describes how spread out individual observations are around the group mean. It is not the same as the uncertainty of a group comparison.

A confidence interval is a general way to express the precision of an estimated contrast. It gives a range of values compatible with the data and the statistical procedure used, under that procedure’s assumptions. A narrower interval generally indicates greater precision, while a wider interval indicates more uncertainty. No confidence interval for the adherence comparison is reported in the registry record, so its precision cannot be assessed.

What does masking mean for interpretation?

Double masking is the registry’s design label. In general, masking is intended to reduce the influence of knowledge about group assignment on care, participant behavior, measurement, or assessment. The practical meaning depends on who was masked and how the intervention was delivered. Because one group receives additional strategies, the registry record does not explain how masking was implemented or which people remained unaware of allocation. The label alone does not show whether masking was successful.

How do the assessment times matter?

The primary outcome is listed at 3 months and 6 months. General analyses of repeated measurements can compare groups separately at each assessment or use a model that incorporates measurements over time. These approaches answer different questions and may rely on different assumptions. A repeated-measures model can account for correlation between observations from the same participant, but its specification and handling of incomplete follow-up matter. The registry does not state which approach was planned or used, nor does it identify a single primary timepoint for the main comparison.

What can a planning illustration tell readers?

In general, sample-size planning estimates how much information a future study might need to detect a defined effect under specified assumptions. The record describes an illustration based on the observed effect, two-sided significance level 0.05, equal allocation, and a normal approximation; for non-time-to-event outcomes, it expresses the planning quantity as participants per arm. It also states that the effect to detect is a stated fraction of the observed effect. Such an illustration is not the trial’s design justification unless the record says it was used for that purpose, and the registry does not report that it was. It is not observed power. The registry record does not report the outcome analyses or the observed effect needed to judge the clinical meaning of a planning illustration.

Finally, statistical significance and clinical importance are distinct general concepts. A p-value, if reported, would summarize compatibility of data with a specified statistical null model; it would not convey the magnitude or practical relevance of an effect on its own. A point estimate and confidence interval would be needed to describe the estimated contrast and its precision. None of these comparative results is reported for the primary outcome.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists medication adherence as the primary outcome and names secondary outcomes of systolic blood pressure, perceived autonomy, perceived competence, mobile device proficiency, and hypertension knowledge level. It also reports seven outcome measures overall, but does not identify all measures or give a statistical plan for handling multiple outcomes or assessment times.

When several outcomes or timepoints are tested, general statistical practice distinguishes the primary question from secondary or exploratory questions. Testing many contrasts can increase the chance of at least one apparently notable result by chance. Methods for controlling or describing this issue depend on the prespecified analysis strategy. No multiplicity adjustment, hierarchy of tests, or designation of confirmatory versus exploratory analyses is reported in the registry record. With zero outcome analyses listed, there are no posted test results to interpret for multiplicity.

Missing-data handling is also not reported in the registry record. The outcome depends on electronic cap-opening records, and the record does not describe rules for incomplete monitoring, lost devices, missed assessments, or unusable readings. It does not report participant flow by assessment or the number contributing to any outcome analysis. Therefore, neither the extent nor the possible influence of missing observations can be assessed from this record.

The analysis population is not reported in the registry record. The record does not say whether analysis was based on randomized assignment, intervention use, available cases, or another population. It also does not explain how the enrollment figures relate to the analyzed population. These omissions limit assessment of both bias and precision. They do not establish that data were missing or that any particular analysis was inappropriate; they mean the posted record does not give enough detail to evaluate those questions.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry lists safety counts for Blood Pressure Technology System M, Blood Pressure Technology System E, and a group labeled Enrolled But Not Randomized/Treated. For System M, the record lists 34 at risk for serious adverse events and 0 affected; it also lists 34 at risk for other adverse events and 0 affected, with 0 deaths. For System E, the corresponding entries are 32 at risk for serious adverse events and 0 affected, 32 at risk for other adverse events and 0 affected, and 0 deaths. For the enrolled but not randomized/treated group, the entries are 134 at risk for serious adverse events and 0 affected, 134 at risk for other adverse events and 0 affected, and 0 deaths.

These are the registry’s recorded counts. They do not establish that no adverse events occurred outside the way the registry categories were defined or reported. The record does not provide serious-event terms, event descriptions, severity, relatedness, observation duration, or further detail on how the safety population was defined. It lists no top serious-event terms.

The groups’ at-risk counts differ from the enrollment figures in other parts of the record, and the registry does not explain the relationship. The safety entries should therefore be read as reported group-level counts rather than as a reconciliation of enrollment or randomized allocation. They do not provide a comparative safety analysis or a measure of uncertainty.

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

The record describes a clinical question about whether adding practical medication-taking and blood-pressure-management strategies to information about hypertension and medication is associated with different medication-adherence measurements. The primary measure uses smart cap openings to derive the percentage of medication taken within the correct timeframe. The assessment schedule includes 3 months and 6 months.

What the registry record does not establish is the observed adherence level in either group or the difference between them. There are no reported outcome analyses, group summaries, effect estimates, confidence intervals, or p-values. The record cannot show from these entries whether adherence changed, whether groups differed at an assessment, or how precise any comparison might be. A completed status is not a substitute for those results.

The measure also has a specific interpretation. Cap-opening records provide an objective record of device use, but the endpoint description does not claim that a cap opening directly verifies ingestion. The record does not explain whether other adherence information was considered or how device-record problems were handled. The measure should therefore be understood according to its stated operational definition, not as a complete account of every aspect of medication use.

The intervention descriptions make clear that System M includes additional strategies beyond the information included in System E. However, the record does not report enough detail to assess the content, consistency, or uptake of those strategies. It also does not say which parts of the broader technology system were common to both groups beyond the brief summary’s statement that both groups use a blood pressure system.

These limitations do not demonstrate a benefit, absence of benefit, or equivalence between approaches. They reflect the difference between a trial’s design description and its posted statistical results. Interpretation of comparative effects would require outcome estimates, their uncertainty, and sufficient information about analyzed participants and missing measurements. Those details are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial addresses medication adherence in older adults with hypertension, a question that depends on both how adherence is measured and how an intervention is compared. The registry’s primary endpoint uses sensor-recorded cap openings to define a percentage taken within the correct timeframe. That makes the operational definition visible and allows readers to distinguish the recorded behavior from self-report or direct confirmation of ingestion.

The trial also describes a useful comparative structure: both groups receive information about high blood pressure and medications, while one group receives additional strategies for medication taking and blood-pressure management. From a statistical perspective, clearly identifying this contrast is essential because it defines what a between-group estimate would represent. The parallel-group randomized design is intended to support such a comparison, although the record does not provide the outcome analysis needed to quantify it.

The assessment schedule raises an important interpretation issue. A comparison at 3 months and a comparison at 6 months concern different points in follow-up, while an analysis using both measurements would need to describe how repeated observations are handled. Without a reported analysis plan or estimates, readers cannot tell which time-specific or longitudinal question was answered.

The registry record also illustrates why enrollment and analysis details matter. The enrollment field lists 200, while the brief summary describes 224 planned participants and 112 per group. The safety information includes a separately labeled group of people not randomized or treated. Without an explanation of these entries or participant flow, the analyzed population and the relationship between planned, enrolled, and analyzed groups remain unclear.

Statistically, a well-described endpoint and randomized design are not enough to assess the result. Readers also need group summaries, a defined contrast, uncertainty, and information about missing data and analysis populations. The registry record’s lack of outcome analyses makes those limits especially important: the design can be described, but comparative effects cannot be evaluated from the posted results.

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 of the registry record is the absence of reported outcome analyses. Although medication adherence is named as the primary outcome and the assessment schedule is given, no adherence values or between-group comparisons are reported. The registry lists zero outcome analyses. This prevents assessment of the magnitude and precision of the primary comparison.

Enrollment is described inconsistently: the enrollment field lists 200, whereas the brief summary says investigators will enroll 224 participants, with 112 per group. The record does not clarify how these figures relate to recruitment, randomization, or the final analysis. Safety counts include a separate Enrolled But Not Randomized/Treated group, but the registry does not explain its relationship to the other entries.

The primary outcome is listed at 3 months and 6 months, but the record does not identify the primary comparison timepoint or explain how measurements across time were analyzed. The randomization and double-masking labels are not accompanied by procedural details. The record also does not report the analysis population, participant flow for outcome data, missing-data methods, or statistical models.

The endpoint relies on cap openings as the basis for the adherence percentage. The registry does not describe how absent or implausible device records were addressed, or whether cap openings were supplemented by another measurement. The listed secondary outcomes and total number of outcome measures also are not accompanied by a multiplicity strategy. These omissions constrain interpretation of both the measurement and the intended statistical evidence.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Improving Hypertension Medication Adherence for Older Adults — NCT05610059.
• Registry record last updated 2026-07-31; status last verified 2026-03.
• Results first posted 2026-07-31.
• 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

The registry describes a completed, randomized, double-masked, parallel-group trial sponsored by the University of Arizona. The target population is older adults with hypertension, and the two interventions are Blood Pressure Technology System M and Blood Pressure Technology System E. Both include information about hypertension and medications; System M additionally includes strategies for taking medication and managing blood pressure.

The primary outcome is Medication Adherence (MEMS Cap), expressed as the percentage of medication taken within the correct timeframe and assessed at 3 months and 6 months. Secondary outcomes include systolic blood pressure, perceived autonomy, perceived competence, mobile device proficiency, and hypertension knowledge level.

The record lists an enrollment of 200, while its brief summary describes 224 planned participants and 112 per group. It reports zero outcome analyses and does not provide comparative primary-outcome results, an analysis population, or missing-data methods. Safety entries list zero serious adverse events, zero other adverse events, and zero deaths in each of the three recorded groups, with their at-risk counts reported separately above.