Get Ready And Empowered About Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Get Ready And Empowered About Treatment (NCT02165735), a randomized na study. The primary outcome is Change in Patient Activation Measure (PAM).

2. Clinical Question

The study asks whether a patient activation program is associated with a difference in patient empowerment after one year, compared with usual HIV care. The primary measure is the Patient Activation Measure (PAM), a scale of knowledge, skill, and confidence for managing health. The registry record describes the study as designed to assess a program intended to empower people living with HIV and improve their health care and health.

The registry describes the primary outcome as change in PAM, while the posted comparison is reported as a mean difference. It does not provide a separate baseline-adjusted estimate or a detailed account of how the comparison was modeled. The result therefore describes the reported group means and their posted contrast; it should not be read as a complete account of each participant’s trajectory or as proof that the intervention caused any observed difference.

3. Trial Design

The registry record identifies NCT02165735 as a randomized, parallel-group study of patient activation training compared with usual care. It lists the allocation as randomized and masking as none. The study is marked completed, with enrollment listed as 360. The record lists a start date of 2014-08-20 and a primary completion date of 2016-11-30. The sponsor is the University of Rochester.

The intervention was behavioral. Its description specifies six 90-minute group training sessions, with 8-12 people per group, facilitated by trained peers and training staff. It also includes a 20-30 minute pre-visit coaching session conducted by staff. The listed hands-on training topics include HIV education and use of a handheld smart device. The registry record’s description does not give a fuller account of the curriculum beyond those listed elements. The comparator is described as usual care for HIV.

The posted primary comparison includes 180 participants in the Patient Empowerment group and 179 in the Standard Care group. These are the group counts attached to the posted outcome results, not a complete account of participant flow. Details such as how many participants were randomized, received the assigned program, completed follow-up, or were included in each analysis are not reported in the registry record. Although multiple imputation is noted for missing or incomplete primary outcome data, the imputation procedure and analysis population are not described.

The registry lists the primary outcome timeframe as baseline and 1 year. It also lists secondary measures spanning eHealth literacy, decisional self-efficacy, perceived involvement in care, communication skills, adherence self-efficacy, self-reported adherence, undetectable viral load, and evidence-based preventative care. The original protocol’s allocation procedures, detailed statistical plan, and planned sample-size justification 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Multiple imputation was used to account for those with missing or incomplete data

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: One patient that was randomized to Standard Care was subsequently found to be ineligible for the study. This resulted in 179 participants in the Standard Care arm, rather than 180.

6. Primary Endpoint

The registry lists the primary outcome as Change in Patient Activation Measure (PAM), measured over Baseline and 1 year.

The primary endpoint is change in the Patient Activation Measure (PAM), a 13-item measure intended to assess a person’s knowledge, skill, and confidence for self-management. Its stated score range is 0-100, with higher scores indicating greater activation. The registry describes four levels: Level 1, 0-47; Level 2, 47.1 - 55.1; Level 3, 55.2 - 67.0; and Level 4, 67.1 - 100. These descriptions give context for the scale, but a group mean does not reveal how individual participants are distributed across levels.

PAM is relevant to this intervention because the program is intended to support patient empowerment and active participation in health care. The study therefore uses a measure aligned with the stated program aim, rather than relying only on clinical measures. The endpoint is reported as a mean with standard deviation, and the measurement timeframe is baseline and 1 year. Multiple imputation is noted as the approach used to account for missing or incomplete primary outcome data.

The registry record does not specify whether the posted group means are follow-up scores, changes from baseline, or estimates from a model that incorporates both measurement times. It also does not report the scoring details beyond the scale description or the prespecified method for comparing groups. The posted mean difference can be interpreted as a difference in the reported group means, while the precise construction of the change estimate is not fully documented in the registry record.

7. Results Posted in the Registry

• Patient Empowerment: mean 73.35 versus 70.53 on control; difference 2.82 (95% CI 2.59 to 3.05), standardized effect d = 2.48; z-test p = <0.001.

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.

Change in eHealth Literacy Scale (eHEALS)

• 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:
  • Patient Empowerment: mean 29.81 versus 27.67 on control; difference 2.14 (95% CI 1.84 to 2.44), standardized effect d = 1.49; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Patient Empowerment than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in Decisional Self-Efficacy Scale (DSES)

• 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:
  • Patient Empowerment: mean 91.89 versus 90.81 on control; difference 1.08 (95% CI 0.90 to 1.26), standardized effect d = 1.25; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Patient Empowerment than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in Perceived Involvement in Care Scale (PICS)

• 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:
  • Patient Empowerment: mean 33.74 versus 32.47 on control; difference 1.27 (95% CI 1.08 to 1.46), standardized effect d = 1.38; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Patient Empowerment than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The posted secondary outcomes cover related but distinct domains: eHealth literacy, decisional self-efficacy, involvement in care, communication skills, adherence-related measures, viral load, and preventative care. For the secondary comparisons with posted numerical results, the estimated mean differences are positive for Patient Empowerment relative to Standard Care. The registry record lists a total of 10 secondary outcomes, but numerical results are posted for only some of them; the full set of secondary outcome results is not available in the record.

The direction of the posted secondary comparisons is broadly consistent with the primary PAM comparison in that the reported means are higher in the Patient Empowerment group for the measures with numerical comparisons. These outcomes may provide context for the primary finding because they address skills, confidence, participation, and related aspects of care. However, they are not interchangeable with PAM, and the secondary measures do not independently establish a change in the primary construct or in health outcomes.

The registry record lists no reported analyses for the secondary outcomes, and the posted secondary p-values are unadjusted. When multiple outcomes are examined, some may appear statistically notable by chance, even if the underlying effects are small or absent. Without a reported multiplicity strategy, a prespecified hierarchy, or complete results for all listed outcomes, the secondary evidence carries less weight than the primary comparison. The secondary findings are best read as supportive patterns rather than definitive confirmation.

Some listed outcomes are clinical or behavior-related rather than scale scores, and their interpretation may depend on definitions and measurement procedures that are not described in the registry record. The record does not give sufficient detail to judge whether missingness, measurement differences, or outcome selection could affect comparisons across the full set. The overall pattern is therefore informative as context, but its strength is limited by incomplete reporting and unadjusted testing.

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

• Change in eHealth Literacy Scale (eHEALS)
• Change in Decisional Self-Efficacy Scale (DSES)
• Change in Perceived Involvement in Care Scale (PICS)
• Change in Instrument on Doctor Patient Communication Skills (IDPCS)
• Change in HIV Adherence Self-Efficacy Scale (ASES)
• Change in Self-Reported Adherence
• Change in Undetectable Viral Load
• Change in Evidence-based Preventative Care

9. Statistical Interpretation

10. Statistical Methods Explained

The registry describes a randomized parallel-group design. In general, random allocation is intended to make treatment groups comparable at the point of assignment, so that later differences can be interpreted against the assigned group comparison. It does not guarantee that groups are identical, and the registry record does not describe the method used to generate or conceal the allocation sequence. The masking field is listed as none. Because PAM is a patient-reported measure, expectations and knowledge of group assignment could be relevant to how responses are given; the record does not report specific procedures addressing that possibility.

What does a mean difference describe?

The PAM result is reported as a mean difference between the Patient Empowerment and Standard Care groups. A mean summarizes the central score across a group. A difference between means expresses the distance between those group averages, in the scale’s units. It does not show that each participant experienced a change equal to the group difference. Individuals may have scores above or below the group mean, and the registry does not provide individual-level distributions.

The registry labels the primary outcome as change and gives a baseline and 1 year timeframe. However, the posted results do not explain whether the reported means are follow-up measurements, change scores, or values estimated by a model using both time points. The registry record also does not report the model specification, covariates, or whether repeated measurements were modeled jointly. Thus, the posted contrast can be described, but its exact analytical construction is not fully documented.

What do the standard deviations contribute?

A standard deviation describes how spread out scores are around the mean. It is different from a standard error, which describes the uncertainty in an estimated mean. The posted primary arm results include standard deviations, and the comparison includes an interval estimate. The standard deviations help characterize within-group variability, while the confidence interval helps characterize precision of the between-group estimate. Neither statistic shows the full distribution or the range of individual outcomes.

In general, the mean and standard deviation are most informative when the scale can be reasonably summarized with those statistics. The registry identifies PAM as a score on a scale and reports a mean and standard deviation. It does not provide histograms, quantiles, or distributional diagnostics, so the shape of the score distribution cannot be assessed from the registry record alone.

How should the p-value be read?

The posted primary p-value is unadjusted and reported as <0.001. In general, a p-value measures how incompatible the observed data are with a specified null model, conditional on the model’s assumptions. It is not the probability that the null hypothesis is true, the probability that the result occurred by chance, or a measure of the size or importance of an effect. The registry does not give the full testing procedure or state whether the primary comparison was prespecified in a protocol available in the record.

The interval estimate gives more information about the range of differences compatible with the analysis than the p-value alone. A narrow interval indicates greater precision than a wide one, while still depending on the validity of the underlying analysis. The posted interval is above zero, but the p-value and interval do not answer whether the difference is meaningful to patients or whether it leads to a change in clinical outcomes.

What does multiple imputation address?

The primary outcome description says multiple imputation was used for missing or incomplete data. In general, multiple imputation uses the observed data to create several plausible completed datasets, analyzes each dataset, and combines the results while accounting for uncertainty due to missing values. Its validity depends on assumptions about why data are missing and on the variables and model used in the imputation. The registry does not report the imputation model, number of imputations, variables included, missingness by group, or sensitivity analyses. The statement that imputation was used is therefore useful but not enough to evaluate its implementation.

The outcome counts in the posted results are 180 and 179, while the enrollment listing is 360. The record does not provide a participant-flow account that explains the difference between those figures, nor does it state how the analysis sets were defined. The imputation note should not be treated as evidence that missing data could not affect the result.

What can the posted secondary analyses establish?

The registry contains several secondary outcomes, and the posted outcome results include comparisons for some of them. The registry record lists no reported analyses for the secondary outcomes. The posted comparison p-values are unadjusted. In general, testing many outcomes increases the chance that at least one result will appear statistically notable even when the underlying effects are absent. Adjustment procedures or a hierarchy of hypotheses can address this concern, but the registry does not describe a multiplicity plan. Secondary results are therefore best considered supportive and exploratory, especially when their status in the analysis plan is not clear.

The record does not report the trial’s original statistical analysis plan, the original sample-size rationale, interim analyses, or stopping rules. Those details cannot be inferred from the posted comparisons. The registry’s planning illustration uses observed effects and stated assumptions, which is distinct from the trial’s original design calculation and does not establish the design rationale.

11. Confidence Intervals and Precision

The primary mean difference is 2.82 points, with a 95% confidence interval from 2.585 to 3.055. The interval gives a range of values compatible with the observed data and the analysis assumptions at the stated confidence level. It is an estimate of uncertainty around the group contrast, not a range expected to contain 95% of individual participants’ scores. The interval is entirely above zero, consistent with the posted unadjusted p-value of <0.001.

The width of an interval reflects both the amount of information available and the variability in the data, as well as features of the analysis. A more precise estimate has a narrower interval. The posted interval is relatively concentrated around the estimate, but precision should not be confused with importance: the registry record does not report a threshold for a meaningful PAM difference. The interval also does not account for uncertainties that may arise from unreported modeling choices, missing-data assumptions, or selective reporting.

The comparison is based on posted group results of 180 participants for Patient Empowerment and 179 for Standard Care. The registry notes use of multiple imputation for missing or incomplete primary outcome data, but it does not report the amount or pattern of missingness or details of the imputation model. Without those details, readers cannot assess how sensitive the interval may be to missing-data assumptions.

Precision of a group mean comparison is different from precision about individual response. A narrow interval for the average difference does not imply that all participants responded similarly, and the registry record does not report individual-level change distributions. The PAM levels provide interpretive ranges for scores, but the posted means and interval do not show how many participants moved between levels or how variable such changes were.

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 sample-size figures are planning illustrations based on the observed effect, not the study’s original design assumptions. The registry lists the planning assumptions as a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning row uses a stated fraction of the observed effect. The original trial’s sample-size justification and design assumptions are not reported in the registry record.

For this continuous outcome, the planning figures are participants per arm, not total events. The 80% power column gives the estimated number of participants needed in each arm for an 80% chance of detecting the assumed effect under the listed planning assumptions, if that assumed effect is the true one. The 90% power column uses a higher target probability of detection and therefore generally requires more participants per arm. These are conditional planning probabilities, not guarantees for a future study.

Rows that plan for 75% or 50% of the observed effect use smaller effects than the row based on 100% of the observed effect. Smaller effects are harder to distinguish from random variation, so they require more participants per arm under the same assumptions. For the primary comparison, the displayed planning figures rise from 3 participants per arm for 80% power and 4 for 90% power at 100% of the observed effect, to 11 and 14 at 50% of the observed effect.

These figures are not observed power. They are sample-size illustrations calculated from the observed result and stated assumptions, not a retrospective measure of the trial’s success and not evidence about the probability that the reported result is true. They also do not substitute for the unreported original design 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 = 2.820; pooled standard deviation σ = 1.135.
2. n = 2 × (1.96 + 0.842)² × 1.135² / 2.820² = 2.5, rounded up to 3 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 <- 2.81999999999999                      # observed difference in means
sigma <- 1.13499700760967                     # 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(2165735)
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 = 3 (80% power), 4 (90% power)
 75% of observed effect: n per arm = 5 (80% power), 7 (90% power)
 50% of observed effect: n per arm = 11 (80% power), 14 (90% power)
power.t.test: 3.8 
Simulated power at n = 3 per arm: 0.630 (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 10 secondary outcomes in addition to the primary PAM outcome. The posted comparison results include unadjusted p-values, and the record does not describe a plan for controlling multiplicity. When several hypotheses are tested, the chance of at least one small p-value can rise even when no true effect exists. In general, prespecified outcome hierarchies, family-wise error procedures, or false-discovery approaches can help address multiple testing. Which approach, if any, was planned or used is not reported in the registry record.

This matters particularly for secondary outcomes. Their results can help assess whether the primary finding fits a wider pattern, but without a stated adjustment strategy and full reporting across outcomes, they should not carry the same evidential weight as a clearly prespecified primary analysis. The registry lists no reported analyses for the secondary outcomes, although some secondary comparisons are posted. It does not explain this distinction or identify which analyses were planned before data were examined.

For missing data, the primary outcome description states that multiple imputation was used to account for missing or incomplete data. This indicates an attempt to address missingness, but key details are absent: the number and pattern of missing observations, the imputation variables and model, the number of imputed datasets, and sensitivity analyses are not reported in the registry record. In general, imputation relies on assumptions about the relationship between missingness and observed or unobserved information. The record does not allow an assessment of whether those assumptions are plausible.

The outcome results list 180 participants in Patient Empowerment and 179 in Standard Care, while enrollment is listed as 360. The registry does not provide a participant-flow diagram or explain analysis-population definitions. The posted numbers should therefore not be assumed to represent every randomized participant, every participant who received training, or every participant who completed follow-up. The exact analysis population and handling of incomplete measurements are not fully reported.

The registry record does not report the original statistical analysis plan, interim analyses, or the trial’s original sample-size justification. These details are important for distinguishing prespecified analyses from exploratory analyses and for understanding how the final analysis was selected. Their absence limits evaluation of multiplicity, missing-data handling, and the overall analysis strategy.

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 lists 180 participants at risk in each group for both serious and other adverse events. It reports 0 participants affected by serious adverse events and 0 affected by other adverse events in Patient Empowerment, and the same figures in Standard Care. Deaths are listed as 0 in both groups. No serious adverse event terms are listed.

These figures describe what was recorded in the registry’s adverse-event results. They do not establish that no adverse events occurred outside the definitions, observation period, or reporting procedures used in the study. The registry record does not describe the adverse-event collection methods, event definitions, follow-up duration for safety reporting, or how missing safety information was handled. The figures should therefore be read as reported counts, not as proof of absence of risk.

The listed groups at risk are not identical to the posted primary outcome counts, and the registry does not explain this difference. Adverse-event counts also do not provide information about event severity beyond the serious/non-serious categories or about exposure time. No comparison of safety rates or formal statistical analysis is reported in the registry record.

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

The posted primary result indicates a higher mean PAM score in the Patient Empowerment group than in the Standard Care group. The mean difference is 2.82 points, with a 95% confidence interval from 2.585 to 3.055 and an unadjusted p-value of <0.001. This is evidence of a statistical difference in the reported group means under the analysis represented by the registry results.

The result does not by itself establish that the difference is important to participants. The registry record does not report a minimum difference considered meaningful, nor does it describe how the score difference translates into changes in daily self-management. The score thresholds provide broad categories, but group averages cannot show how many individuals changed categories, improved, or remained unchanged.

The comparison also does not establish that the program caused improvements in clinical health or care outcomes. The intervention was designed around patient activation, and PAM measures knowledge, skill, and confidence for self-management. Other listed outcomes address related topics, but the record does not provide complete numerical results for all of them or a multiplicity plan. A difference on PAM should not be treated as a substitute for evidence on outcomes such as adherence, viral load, or preventative care.

Randomization supports comparison between assigned groups, but masking is listed as none. The record does not report adherence to the intervention, engagement with sessions, co-interventions, or the exact analytic approach. Nor does it give enough information to assess the effect of missing data in detail. These factors affect how confidently the group contrast can be interpreted as an intervention effect.

The record supports a precise description of the posted mean comparison, while leaving important questions about clinical meaning, individual variability, analytic choices, and broader outcomes unresolved. It is appropriate to distinguish the statistical result from claims that go beyond the measures and reporting available.

17. Why This Trial Matters Statistically

This trial is statistically notable because it compares a behavioral program with usual care using a patient-reported measure closely aligned with the program’s stated aim. The primary outcome, PAM, focuses on knowledge, skill, and confidence for self-management. That alignment makes the endpoint relevant to the intervention question, while also making interpretation dependent on understanding what the scale captures and what it does not.

The randomized parallel-group structure supports a direct comparison of group means. The posted interval estimate and p-value communicate different aspects of the result: the interval indicates the uncertainty around the estimated difference, while the p-value expresses compatibility with a null model under analysis assumptions. Neither substitutes for a threshold of practical importance, which is not reported in the registry record.

The record also illustrates why statistical evidence should be considered alongside reporting completeness. Multiple imputation is noted for the primary outcome, but details of missingness and the imputation procedure are absent. There are multiple secondary outcomes, yet the multiplicity plan and complete numerical results are not available. These gaps do not erase the posted primary comparison, but they constrain the scope and strength of conclusions that can be drawn from the overall result set.

Finally, the sample-size illustrations are based on observed effects rather than the original design rationale. They can show how planning requirements change as the assumed target effect becomes smaller, but they cannot explain how the completed trial was designed or provide observed power. Keeping those statistical questions separate helps readers avoid treating a significant result, a precise estimate, and a clinically meaningful result as equivalent claims.

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.

Several limitations specific to this record affect interpretation. The masking field is listed as none, and the primary outcome is a patient-reported scale. Participants knew whether they received group training and coaching, so responses could be influenced by expectations or engagement. The registry does not report procedures to assess or reduce such influences.

The intervention description gives the session schedule, group size, facilitators, coaching, and two listed training topics, but the curriculum description is incomplete. The record does not report attendance, intervention fidelity, participant engagement, or how much of the program each participant received. It is therefore not possible to evaluate dose received or distinguish the contributions of group sessions, coaching, HIV education, and device use.

The primary outcome is described as change from baseline to 1 year, but the posted results do not fully explain how the reported means and difference relate to those measurements. Baseline outcome values, participant-level changes, subgroup results, and distributions across PAM levels are not reported. The exact analysis model and covariate adjustment are also not reported in the registry record.

Multiple imputation is noted, but the amount and pattern of missing data and the imputation details are absent. The record also does not provide a participant-flow account that connects enrollment with the outcome counts. Without this information, it is difficult to assess the analysis population and the sensitivity of the result to missing observations.

Finally, the registry lists many secondary outcomes but provides incomplete numerical reporting and no stated multiplicity procedure. The original sample-size justification, detailed protocol, and statistical analysis plan are not reported in the registry record. These limitations chiefly restrict assessment of the analysis process and the breadth of inference; they should not be mistaken for evidence that the posted mean comparison is incorrect.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Get Ready And Empowered About Treatment — NCT02165735.
• Registry record last updated 2019-03-15; status last verified 2019-02.
• Results first posted 2018-10-09.
• 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

NCT02165735 is a completed, randomized, parallel-group study sponsored by the University of Rochester. It compares patient activation training with usual care for HIV and lists enrollment of 360. Masking is listed as none. The intervention includes six 90-minute group sessions and one 20-30 minute pre-visit coaching session.

The primary outcome is change in Patient Activation Measure score from baseline to 1 year. The posted mean difference for Patient Empowerment versus Standard Care is 2.82 points, with a 95% confidence interval from 2.585 to 3.055 and an unadjusted p-value of <0.001. Multiple imputation is noted for missing or incomplete primary outcome data, but its details are not reported.

The registry lists 10 secondary outcomes, with incomplete numerical reporting and no described multiplicity plan. It reports 0 serious adverse events, 0 other adverse events, and 0 deaths in each group. The original statistical analysis plan, sample-size justification, detailed missing-data information, and participant flow are not reported in the registry record.