Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence (NCT04585594), a randomized na study. The primary outcome is Medication Adherence (Objective).

2. Clinical Question

The central statistical question is a comparison between two behavioral approaches under usual care, rather than a comparison of either approach with no intervention. The outcome captures recorded bottle openings as an indication of pill-taking behavior. It is therefore an objective measure of medication-taking patterns, but the registry’s definition does not establish that every opening corresponds to a dose actually taken. The record identifies the analyzed population by availability of complete MEMS data; it does not explain how participants without complete data were handled in other analyses.

3. Trial Design

This was a randomized, parallel-group trial of two behavioral educational interventions for adults with uncontrolled hypertension. The registry lists an enrollment of 511 and identifies the study status as completed. The sponsor was the University of California, Irvine. The recorded phase is NA. The study began on 2020-09-16, and primary completion was recorded as 2024-09-10.

The two arms were Mi Propio Camino (MPC; My Own Way) and Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control). Both were delivered alongside usual care for hypertension. The registry identifies the allocation as randomized, masking as none, and the model as parallel. Thus, the listed design has separate groups receiving their assigned intervention rather than a crossover arrangement, and the study was not masked according to the registry record. Further details about randomization procedures, allocation concealment, or who knew assignments are not reported in the registry record.

The primary outcome was medication adherence measured at six months post-intervention. Its analysis population consisted of participants with complete MEMS cap adherence data at that follow-up. The displayed primary group summaries include 143 participants in MPC and 161 in HCP. These analysis counts are not the same as the overall enrollment and should not be read as a complete accounting of participant flow. Reasons for the difference, and details of missing primary outcome data, are not reported in the registry record.

The registry lists nine outcome measures and zero reported analyses. It identifies subjective medication adherence, nonadherence due to beliefs, medication-related beliefs, systolic blood pressure, and diastolic blood pressure among secondary outcomes. Results are posted for three secondary measures in the available record; systolic and diastolic blood pressure results are not included in the posted outcome details used. Protocol details, including a statistical analysis plan and the original design assumptions, 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Participants with complete MEMS cap adherence data at 6-month follow-up were included in this analysis.

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: All randomized participants.

6. Primary Endpoint

The registry lists the primary outcome as Medication Adherence (Objective), measured over 6 months post-intervention.

The primary endpoint is medication adherence at six months post-intervention, measured as percent days adherent. The registry describes assessment using Medication Event Monitoring System (MEMS) pill bottle cap monitors. These caps record each time a medicine bottle is opened, and the outcome definition treats an opening as an indication of medication-taking behavior. Daily adherence is defined as the proportion of days during a 30-day period on which the prescribed number of doses was taken.

This objective measure is used to capture behavior through recorded bottle openings rather than relying only on a participant’s report of adherence. It can provide a record of patterns over the measurement period, but the monitor records bottle opening, not ingestion itself. The endpoint should therefore be understood according to the registry’s operational definition and not as a direct confirmation that medication entered the body on every recorded occasion.

The posted outcome is a continuous measure summarized by a mean and standard deviation for each intervention group. The primary analysis population was restricted to participants with complete MEMS adherence data at the specified follow-up. The registry does not report further detail about how incomplete monitoring records were defined, whether adherence was summarized across multiple medicines, or how missing or unusable monitor data were handled.

7. Results Posted in the Registry

• Mi Propio Camino (MPC; My Own Way): mean 54.90 versus 64.20 on control; difference -9.30 (95% CI -17.85 to -0.75), standardized effect d = -0.25; z-test p = 0.033.

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.

Medication Adherence (Subjective)

• 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:
  • Mi Propio Camino (MPC; My Own Way): mean 5.40 versus 5.70 on control; difference -0.30 (95% CI -0.68 to 0.08), standardized effect d = -0.18; z-test p = 0.123.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Mi Propio Camino (MPC; My Own Way) and the control. The interval gives the range of effects that remain compatible with the data.

Number of Participants Who Were Nonadherent Due To Beliefs (Subjective)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Mi Propio Camino (MPC; My Own Way): 41.3% (62/150) versus 42.3% (71/168) on control; risk difference -0.9 percentage points (95% CI -11.8 to 9.9), risk ratio 0.98 (0.75–1.27); unadjusted two-proportion z-test p = 0.867.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Mi Propio Camino (MPC; My Own Way) and the control. The interval gives the range of effects that remain compatible with the data.

Medication-related Beliefs (Specific)

• 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:
  • Mi Propio Camino (MPC; My Own Way): mean 3.30 versus 3.50 on control; difference -0.20 (95% CI -1.30 to 0.90), standardized effect d = -0.04; z-test p = 0.722.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Mi Propio Camino (MPC; My Own Way) and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary results cover subjective medication adherence, nonadherence attributed to beliefs, and medication-related beliefs. Their pattern does not reproduce a clear, consistent separation favoring the same intervention across all measures. This contrasts with the primary MEMS-based comparison, which has an unadjusted interval lying below zero for MPC minus HCP. The secondary measures address related but distinct aspects of adherence and beliefs, and their results should not be treated as interchangeable with the objective primary endpoint.

Subjective adherence and beliefs rely on different kinds of measurement than recorded bottle openings. The binary count of participants classified as nonadherent due to beliefs also differs from a continuous mean score. Differences in measurement and scale mean that directions and magnitudes cannot be compared directly across these endpoints. The registry record does not give further instrument or scoring details beyond the listed measure descriptions and units.

Secondary findings generally carry less confirmatory weight when multiple outcomes are examined without a reported multiplicity adjustment or prespecified testing hierarchy. Each additional comparison creates another opportunity for an apparently notable result by chance. The registry record lists nine outcome measures and zero reported analyses, and it does not describe how secondary hypotheses were prioritized or adjusted. Accordingly, the secondary outcomes can add context, but they should not be used to overturn or definitively corroborate the primary result.

The listed secondary outcomes also include systolic and diastolic blood pressure, but results for those measures are not reported in the registry record. Their absence from the posted result details should not be interpreted as no change or no difference. Overall, the secondary outcomes provide a limited and incomplete view of whether the primary adherence contrast aligns with other measures. They do not establish a broader pattern of effects across adherence, beliefs, and blood pressure.

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

• Medication Adherence (Subjective)
• Number of Participants Who Were Nonadherent Due To Beliefs (Subjective)
• Medication-related Beliefs (Specific)
• Systolic Blood Pressure
• Diastolic Blood Pressure

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous: it is a percent-days-adherent measure summarized with a mean and standard deviation. A mean gives the arithmetic average of the recorded outcome within a group. A standard deviation describes how spread out individual values are around that group mean. It is not the uncertainty interval for the mean difference. In this trial, the means are 54.9 for MPC and 64.2 for HCP, while the standard deviations are 38.7 and 37.1, respectively.

The posted comparison is a mean difference. Its direction depends on the order of subtraction: the estimate is MPC minus HCP. The value of -9.3 therefore means that the MPC group mean was lower than the HCP group mean by 9.3 percentage points in the analyzed data. The sign does not independently indicate benefit or harm; interpretation requires knowing which group is subtracted from which and what the outcome represents.

A confidence interval gives a range of values compatible with the estimate under the statistical method and its assumptions. For the primary mean difference, the reported interval does not include zero. For a difference measure, zero represents no difference in group means. The interval’s location below zero is consistent with the direction of the posted estimate. It does not mean that there is a specified probability that the true value lies within that particular interval, nor does it describe the range of individual adherence scores.

The p-value is an unadjusted test statistic for the comparison. In general, it describes how incompatible the observed data are with a null model of no group difference, assuming that model and the analysis assumptions apply. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect. The posted primary p-value is 0.033. The registry record does not report whether the test was prespecified, whether other analyses were conducted but not posted, or whether an adjustment for multiple testing was planned.

The primary comparison uses the posted group summaries and is unadjusted. A simple comparison based on summary data does not account for baseline covariates, site, or other possible influences unless such adjustment is specifically reported. No adjusted primary result is included in the registry record. The record also does not report the exact inferential procedure used for the posted comparison or a full statistical analysis plan. The interval and p-value are therefore best interpreted as the posted unadjusted summaries rather than as a complete account of all planned analyses.

The endpoint is based on repeated recording of bottle openings over a 30-day period, but the reported analysis treats the participant-level adherence measure as continuous. Aggregating behavior into a percentage can make group means easy to compare, while obscuring details such as timing or patterns within the measurement period. The registry defines the measure in terms of the proportion of days when the prescribed number of doses was taken; the cap’s direct record is bottle opening. This distinction matters because an opening is a behavioral proxy and not direct confirmation of ingestion.

The observed standard deviations are large in relation to the group means, suggesting considerable participant-to-participant variation in this measure. In general, high variability makes it harder to estimate a group mean difference precisely, because individual outcomes carry less uniform information about the group average. Here, precision should be judged using the confidence interval rather than the standard deviations alone. Differences in observed variability do not establish why outcomes vary, and the registry record does not report a model for explaining that variation.

Randomization is intended, in general, to support fair comparisons by balancing prognostic factors across groups on average. It does not guarantee identical groups in a particular trial, and the credibility of a randomized comparison also depends on implementation, follow-up, and analysis choices. The registry identifies randomized allocation, but does not report procedural details sufficient to assess sequence generation, concealment, or balance at baseline. No claims about these aspects can be made from the outcome summaries alone.

Masking is recorded as none. In general, lack of masking can influence behavior, reporting, intervention delivery, or outcome assessment, depending on who knows group assignment and how outcomes are collected. MEMS is an objective recording method, but that does not eliminate every possible source of bias. The registry record does not describe which staff or participants knew assignments, or whether outcome data were assessed without knowledge of group. These limitations should be kept distinct from the numerical uncertainty represented by the confidence interval.

Over-dispersion is relevant when a statistical model assumes less variability than the data contain. In general, if such excess variability is ignored, standard errors may be too small and confidence intervals too narrow. The posted primary outcome is a continuous measure with substantial observed spread, but the registry record does not describe an over-dispersion assessment or model-based correction. It would therefore be inappropriate to assert that such a correction was used or needed. The group standard deviations alone do not identify the correct model.

The reported outcome population consists of participants with complete MEMS adherence data at follow-up. In general, complete-case analysis can be biased if the availability of complete data is related to adherence or group assignment. The direction and size of any such bias cannot be inferred without information about missingness and the people whose outcome data were unavailable. The registry record does not report those details. The analysis counts should be understood as counts with available complete outcome data, not as proof that missingness was inconsequential.

11. Confidence Intervals and Precision

For a mean difference, the confidence interval communicates uncertainty about the estimated separation between group averages. The primary estimate is -9.3 percentage points for MPC minus HCP, and the reported interval lies entirely below zero. This makes the direction of the posted estimate more precise than an interval that included zero, under the method used. The interval still allows a range of possible differences; it does not identify a single exact underlying effect.

The interval should not be confused with the range of individual outcomes. The group standard deviations, 38.7 for MPC and 37.1 for HCP, describe variation among analyzed participants, whereas the confidence interval concerns uncertainty in the group contrast. Many individual adherence values can vary widely even when the interval for the mean difference excludes zero. Conversely, a narrow interval would not imply that individual outcomes are similar.

The primary result is unadjusted, and the registry record does not provide an adjusted interval for comparison. Nor does the record explain how participants without complete MEMS data might affect precision or the estimate. The interval reflects the posted analysis and its assumptions; it cannot account for uncertainties from missing data or unreported design and analysis choices.

For secondary measures, several reported intervals include zero or span values on both sides of zero. Such intervals indicate that the corresponding unadjusted estimates are not precise enough to rule out no difference using that interval criterion. This is not proof of equivalence. The primary interval’s exclusion of zero also does not remove the need to consider the number of outcomes and analyses, because uncertainty in an individual comparison is different from the chance of finding an apparently notable result across multiple comparisons.

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 illustrations based on the observed effect, not the trial’s original design calculation. For these continuous and binary outcomes, the entries are participants per arm, rather than total events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; each scenario uses the stated fraction of the observed effect. The original design assumptions for the trial are not reported in the registry record.

The 80% power column gives the planned number of participants per arm for a hypothetical study to have an 80% chance of detecting the specified effect under those assumptions, if that effect and model were correct. The 90% column describes the corresponding planning target for a 90% chance. These are design probabilities for a future study, not probabilities that the observed result is true. They are not observed power.

Rows that plan for a smaller fraction of the observed effect require more participants per arm. That follows because smaller differences are harder to distinguish from ordinary sampling variation under a fixed analysis approach. The planning estimates are especially sensitive to the effect used: the observed difference may not be a stable estimate of the effect a future trial should target. For a binary outcome, the planning illustration is tied to the observed risk difference and the listed assumptions; it should not be interpreted as a forecast of the number of people who will be nonadherent.

These calculations do not establish that the completed trial was adequately or inadequately sized. The record does not report its original target, design effect, anticipated loss to follow-up, or original power assumptions. The sample-size figures are therefore best read as conditional planning scenarios, not as a reconstruction of the trial’s original rationale.

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 = -9.300; pooled standard deviation σ = 37.861.
2. n = 2 × (1.96 + 0.842)² × 37.861² / -9.300² = 260.2, rounded up to 261 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 <- -9.3                      # observed difference in means
sigma <- 37.8607408190098                     # 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(4585594)
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 = 261 (80% power), 349 (90% power)
 75% of observed effect: n per arm = 463 (80% power), 620 (90% power)
 50% of observed effect: n per arm = 1,041 (80% power), 1,394 (90% power)
power.t.test: 261.1 
Simulated power at n = 261 per arm: 0.800 (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

The registry lists nine outcome measures, including the primary adherence outcome and several secondary outcomes. It reports zero analyses, and the record does not describe a testing hierarchy, a family of primary hypotheses, or a multiplicity adjustment. When many outcomes or comparisons are evaluated, the chance of at least one apparently small p-value can rise even if there are no true effects. This general issue means the unadjusted primary p-value should be interpreted in the context of the outcome set and the absence of reported multiplicity methods. It does not by itself establish that the result is spurious.

The primary analysis includes participants with complete MEMS adherence data at six months post-intervention. The group summaries contain 143 MPC participants and 161 HCP participants. The overall enrollment was 511, but the registry information does not explain the outcome-data flow or the reasons that fewer participants appear in the primary analysis. It does not report missingness by group, reasons for missing data, or an approach such as imputation or sensitivity analysis.

Missing outcome data matter if data availability is related to the outcome, intervention assignment, or factors associated with adherence. In that situation, the analyzed participants may not represent all randomized participants in the same way across groups. This is a general concern, not proof that bias occurred in this trial. Without detail about missingness and analysis populations, the direction or magnitude of any effect cannot be evaluated from the registry record.

The record does not report whether the primary analysis followed an intention-to-treat approach, whether participants were analyzed according to assignment, or how deviations from the assigned intervention were handled. It also does not report an adjusted model or a complete statistical analysis plan. These omissions limit assessment of the analysis strategy and how closely it corresponds to the randomized design. The available statistics remain descriptive of the posted analysis population and should not be generalized beyond that evidence without caution.

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 0% reporting threshold.

The registry’s adverse-event figures list zero serious adverse events in the MPC group and zero in the HCP group. The recorded counts of other adverse events are also zero in both groups, and deaths are recorded as zero in each group. The numbers listed as at risk are 255 for MPC and 256 for HCP for both serious and other adverse events.

These are the safety counts reported in the registry record. They do not establish that no adverse events occurred outside the reported collection or reporting process, and they do not provide detail about monitoring procedures, event definitions, or follow-up completeness. The at-risk counts are safety denominators and differ from the primary outcome analysis counts based on complete MEMS data. Safety figures should not be substituted for the adherence analysis population or interpreted as a comparison of event rates beyond the recorded zero counts.

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

The primary result is a difference in observed mean adherence between participants with complete MEMS data in the two randomized intervention groups. The mean was 54.9 percent days adherent for MPC and 64.2 for HCP, with an unadjusted mean difference of -9.3 percentage points for MPC minus HCP. The reported confidence interval lies below zero, and the unadjusted p-value is 0.033. These statistics describe the posted comparison and its uncertainty.

The result does not show that every participant in HCP had higher adherence than every participant in MPC. The standard deviations indicate substantial variation within both groups. Nor does the result demonstrate that the difference arose from a particular component of either educational intervention. The registry record does not report an analysis that identifies a mechanism or separates intervention effects from other possible influences.

The measure is based on bottle openings as an indication of medication-taking behavior. It does not directly verify ingestion. The findings also pertain to the analysis population with complete MEMS data at follow-up; the record does not explain how those without complete measurements were handled or whether their outcomes differed. The comparison is unadjusted, and the record does not report the full analysis plan or multiplicity handling.

The trial compared two behavioral interventions, each alongside usual hypertension care. It did not compare either intervention with no intervention or with usual care alone. Therefore, the posted contrast cannot determine the effect of either intervention relative to usual care without the educational component. The record also lists blood pressure outcomes but does not report their results in the outcome details used.

Statistical evidence about a difference is not, by itself, a judgment about clinical importance. The registry record does not specify a threshold for a meaningful change in adherence, and the comparison does not establish whether a difference would translate into blood-pressure changes or other outcomes. The numbers support a description of the measured adherence contrast, not medical advice or a definitive conclusion about treatment value.

17. Why This Trial Matters Statistically

This trial illustrates how the choice of endpoint shapes interpretation. MEMS monitoring offers an objective record of bottle openings, while subjective adherence and belief measures capture other facets of behavior and experience. These measures can complement one another, but they do not represent the same construct or share the same measurement limitations. Statistical interpretation requires attention to how each outcome is defined, who contributed data, and what comparison the design supports.

The study also highlights the distinction between a randomized design and a fully documented analysis. Randomization is a valuable basis for comparison, but the registry record does not report allocation procedures, an analysis plan, an adjusted estimate, or a missing-data strategy. Those details influence how confidently readers can connect an observed contrast to the intervention assignment. Numerical results do not replace information about how participants were assigned, followed, and analyzed.

Finally, the contrast is between two active educational interventions used alongside usual care. This is a useful question for comparing approaches, but it differs from asking whether either intervention improves outcomes relative to usual care alone. The primary result and secondary outcome pattern must be interpreted within that comparator structure. The unadjusted primary estimate provides a clear statistical contrast, while missing analysis details and incomplete secondary reporting constrain broader conclusions.

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 primary outcome analysis is restricted to participants with complete MEMS adherence data at six months post-intervention. The registry record does not explain missingness, participant flow, or whether the analyzed groups represent all randomized participants. This limits assessment of potential selection bias and the applicability of the estimate to everyone enrolled.

The primary comparison is unadjusted, and no adjusted result or detailed statistical analysis plan is reported. The record does not say whether baseline adherence was measured or how baseline characteristics were handled. It also does not describe how adherence values were calculated when participants used more than one medication or when monitoring records were incomplete.

Masking is recorded as none. MEMS provides an objective record of bottle openings, but it does not directly observe ingestion, and lack of masking may affect aspects of behavior or study conduct. The registry does not describe who knew assignments or how outcome measurement was managed. The extent of any resulting bias cannot be determined from the posted summaries.

There is no reported multiplicity procedure despite a list of nine outcomes, and the registry lists zero reported analyses. The secondary results are therefore difficult to interpret as a confirmatory set. Systolic and diastolic blood pressure are listed as secondary outcomes, but their results are not reported in the outcome details used. Finally, the trial compares two behavioral approaches alongside usual care, so the record does not establish the effect of either approach relative to usual care alone.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence — NCT04585594.
• Registry record last updated 2026-02-24; status last verified 2026-02.
• Results first posted 2026-02-24.
• 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

The registry record describes a completed, randomized, parallel-group trial comparing Mi Propio Camino with Habilidades para Controlar la Presion, with both interventions delivered alongside usual hypertension care. The primary endpoint was MEMS-measured medication adherence at six months post-intervention among participants with complete adherence data. The posted unadjusted mean difference was -9.3 percentage points for MPC minus HCP, with an unadjusted p-value of 0.033 and a confidence interval lying below zero.

Interpretation is limited by substantial variation in adherence, the complete-data analysis population, and the absence of reported detail on missing-data handling, multiplicity, and the statistical analysis plan. Secondary results do not form a consistent pattern, and the listed blood pressure outcomes lack reported results in the outcome details. The record supports a description of the measured contrast between these two active interventions, not a comparison with usual care alone.