SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study (NCT02741700), a randomized na study. The primary outcome is Medication Adherence.

2. Clinical Question

This question links a communication intervention to a behavior that can be measured repeatedly. The proposed rationale is that stories told in patients’ own voices may help listeners recognize disease severity, consider medication barriers and benefits, and respond to cues to action. That rationale is the study’s conceptual basis; it is not itself evidence that adherence changed in this trial. The registry lists the study as randomized, with no masking and a parallel design. Its stated objective is broader than the primary outcome: the study also lists gout flares, patient satisfaction, and target serum urate as secondary outcomes. The record does not provide results for those outcomes either.

3. Trial Design

The registry identifies NCT02741700 as the STRIDE-GO2 study, with the title “SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study.” It lists the sponsor as the VA Office of Research and Development and the status as completed. The recorded study start date is 2017-05-31, and the primary completion date is 2020-12-31. Enrollment is listed as 306. The phase entry is NA.

The design is randomized, parallel-group, and unmasked. In a parallel design, participants are assigned to one group and the groups are compared over the study period; the registry does not describe a crossover between interventions. The intervention group received a gout storytelling video, while the comparison group received a video about managing another chronic condition. The registry describes the comparison video as approximately the same duration as the experimental video. It does not give details about allocation concealment, the randomization sequence, or the personnel responsible for assignment.

The primary outcome is medication adherence, measured directly with Medication Event Monitoring System Caps and expressed as the percentage of days urate-lowering therapy was taken. Assessments are listed at 3, 6, 9, and 12 months. The description says the earlier assessments were intended to assess the intervention’s effect and the 12-month assessment its durability. The registry also lists gout flares, patient satisfaction, and target serum urate as secondary outcomes, but does not provide their results.

The record does not report the recruitment setting, detailed eligibility criteria, intervention delivery procedures, adherence thresholds, or follow-up completion by group. It also does not report a statistical analysis plan or explain the basis for the enrollment target. These omissions limit how fully the planned design and conduct can be reconstructed from 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:

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, measured over 3, 6, 9, and 12 months.

The primary endpoint is medication adherence, expressed as the percentage of days urate-lowering therapy was taken. The registry says adherence was directly measured using Medication Event Monitoring System Caps. This is a repeated measure, with assessments scheduled at 3, 6, 9, and 12 months. The record describes the earlier assessments as addressing the intervention’s effect and the last assessment as addressing durability.

As a general measurement principle, an adherence measure based on recorded medication-container use can provide a behavioral indicator over time, rather than relying only on a participant’s general recollection. It is still important to distinguish what the device records from whether medication was swallowed as prescribed: the registry’s endpoint is the percentage of days therapy was taken as measured with the caps, and the record does not describe any additional confirmation of medication ingestion.

A continuous percentage outcome can retain information across a range of adherence levels. A comparison of group means can describe average adherence, but its interpretation depends on the actual estimates, their uncertainty, the analysis population, and how repeated measurements were handled. Those primary outcome estimates and analysis details are not reported in the registry record. Consequently, the measurement and schedule are described, but the observed adherence pattern and the precision of any group comparison cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, parallel-group study with no masking. These design features define how the comparison is structured, but do not supply the statistical methods used to analyze the outcomes. The registry record does not report an analysis plan, model specification, adjustment variables, or hypothesis-testing procedure. The concepts below are general explanations of methods that may be relevant to a continuous, repeated outcome; they are not claims about methods used in this trial.

What does a mean represent?

The primary outcome is a continuous measure: the percentage of days urate-lowering therapy was taken. A group mean represents the average value in that group under the defined measurement and analysis rules. A mean can be useful for comparing overall adherence levels, but it does not show the full distribution. Participants may have different adherence patterns even when their group averages are similar. The registry identifies the primary parameter as a mean, but does not report the group means or the comparison between them.

As a general statistical principle, a mean comparison is most interpretable when the outcome definition, measurement window, and analysis population are clear. For a repeated endpoint, the chosen summary might be a comparison at one visit, comparisons at several visits, or a model using all available visits. Those choices answer related but not identical questions. The registry lists 3, 6, 9, and 12 months but does not state which summary or model was used for the primary analysis.

What does a confidence interval convey?

The registry describes the outcome’s dispersion as a 95% confidence interval, but it does not give the interval limits for any group or contrast. In general, a confidence interval expresses the uncertainty around an estimate under the assumptions of the statistical procedure used. A narrower interval indicates greater precision under that procedure; a wider interval indicates less precision. It is not a guarantee that the true value lies within the particular interval, nor does it resolve whether the analysis assumptions are appropriate. Without the estimate and interval, the precision of the primary outcome comparison cannot be judged.

A confidence interval for each group mean is not the same as a confidence interval for the difference between groups. The latter directly addresses the contrast of interest. The registry record does not report which interval was calculated or provide any interval values, so no conclusion about overlap or comparative uncertainty is possible.

Why do repeated measurements require care?

Repeated observations from the same participant are generally related rather than independent. As a general statistical principle, a method that analyzes repeated observations should account for that within-participant relationship when estimating uncertainty. Treating every observation as independent can make uncertainty appear smaller than it is. A longitudinal model or a prespecified summary can address repeated observations in different ways, with different assumptions and interpretations. The registry lists multiple follow-up assessments but does not report the method used to account for them.

Repeated outcomes can also be incomplete. Participants may have measurements at some visits but not others. The consequences depend on why observations are missing and on the analysis method. General approaches may use observed data under stated assumptions, model the missingness process, or use other prespecified procedures. The registry does not report the amount or pattern of missing adherence data, reasons for missingness, or how missing values were handled.

Why can over-dispersion matter?

As a general concept, over-dispersion occurs when observed variability is greater than a statistical model assumes. It is especially relevant to outcomes modeled as counts or events, where an overly restrictive variance assumption can understate uncertainty. The primary endpoint is described as a continuous mean, and the registry does not report an over-dispersion model or a method for the secondary outcomes. It would be inappropriate to infer that any particular model or correction was used.

For a percentage outcome, the possible distribution and variance can depend on how observations are measured and on how values cluster near the limits of the scale. General modeling choices should fit the observed data and the scientific question. The record does not provide outcome distributions or diagnostics, so the adequacy of any modeling assumptions cannot be assessed.

What can a planning illustration tell readers?

Planning calculations are not observed trial findings. The registry’s description of its sample-size assumptions characterizes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is stated as a fraction of the observed effect. Such calculations are useful only as planning illustrations and should not be described as observed power. The registry record does not report a sample-size justification as part of the trial’s own design, and no numerical planning results are included in the available record details.

The record also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. This is important because selecting among several visits or outcome measures can affect how results should be interpreted. The statistical plan for selecting or combining assessments, and any approach to multiple comparisons, is not reported in the registry record.

In short, the registry specifies the endpoint’s scale, measurement method, and timing, but not the inferential procedures or numerical results required to evaluate the treatment contrast. General statistical concepts can clarify what those procedures would address; they cannot substitute for the missing estimates and analysis details.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a study evaluates several outcomes, time points, or statistical contrasts. As a general principle, the more comparisons considered, the more important it is to specify in advance which comparison is primary and how secondary or exploratory findings will be interpreted. The registry identifies medication adherence as the primary outcome and lists assessments at 3, 6, 9, and 12 months. It also lists gout flares, patient satisfaction, and target serum urate as secondary outcomes. The record does not report a multiplicity procedure, a hierarchy of comparisons, or how the several adherence time points were handled in the primary analysis.

Missing data can affect both estimates and their uncertainty. The registry does not report outcome completion by group, reasons for missing observations, or methods used to handle missing data. Without that information, it is not possible to determine whether incomplete follow-up could have changed the interpretation of the adherence results.

The record lists no analysis entries. It does not report whether the primary analysis followed randomized assignment, included only participants with available measurements, or used another analysis population. The registry also does not specify whether participants were analyzed according to their original assigned group or whether any exclusions occurred after randomization. These details matter because an analysis population can affect what comparison an estimate represents.

As a general principle, reporting a prespecified primary analysis alongside transparent information about missingness and secondary analyses helps readers distinguish confirmatory evidence from exploratory patterns. Those details are not reported in the registry record, and the primary outcome estimates themselves are also absent.

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 3% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists serious adverse events for both groups. For the Gout Storytelling Video group, the number at risk for serious events is 152 and the number affected is 0. For the Video About Management of Another Chronic Condition group, the number at risk is 154 and the number affected is 0. The registry also lists other adverse events: 9 in the storytelling-video group and 5 in the comparison group. Deaths are listed as 4 and 5, respectively.

These entries are counts, not a complete comparative safety analysis. The record does not report event definitions, timing, severity, relatedness to the intervention, or whether events were counted by participant or by occurrence. It also does not provide statistical comparisons or uncertainty intervals for these safety entries. The absence of listed serious events in the groups should therefore be read narrowly as a registry count, not as proof that serious risk was absent. The terms for the most common serious events are not reported in the registry record.

Safety interpretation also depends on how events were collected and on the period of observation. Those details are not reported in the registry record. The posted counts alone do not establish whether the groups differed in safety.

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

The registry record establishes that a randomized comparison was conducted between a gout storytelling video and a video about management of another chronic condition. It identifies medication adherence as the primary endpoint, measured with Medication Event Monitoring System Caps and assessed at 3, 6, 9, and 12 months. It also records selected adverse-event and death counts. Those details describe the study question and some elements of its conduct.

The record does not report estimates of medication adherence by group, a between-group effect estimate, or confidence intervals. It therefore does not show whether adherence was higher, lower, or similar between the groups, nor how precisely a comparison was estimated. The absence of reported results should not be interpreted as evidence of no effect or equivalence.

The stated rationale proposes that culturally relevant stories in patients’ own voices may influence perceptions and medication behavior. That rationale explains why the intervention was studied; it does not establish that the proposed mechanism occurred or that the intervention changed adherence. The record does not report measures of the proposed communication mechanisms.

The comparison is against another narrated video, described as addressing stress management. A comparison between these groups would be specific to these intervention conditions and would not directly answer how the storytelling video compares with no video or with every other form of adherence support. The registry also lists secondary outcomes, but does not report their results.

Accordingly, the available registry information supports a cautious account of the design, measurement, and recorded safety counts. It does not support a conclusion about the size, direction, clinical importance, or durability of an adherence effect. Further statistical interpretation would require the posted outcome estimates, their uncertainty, and information about analysis methods and missing data.

13. Why This Trial Matters Statistically

This trial is statistically notable for linking a behavioral intervention to a repeated, objectively monitored adherence measure. Rather than relying only on a one-time report, the registry describes Medication Event Monitoring System Caps and expresses adherence as the percentage of days urate-lowering therapy was taken. The assessments at 3, 6, 9, and 12 months create the possibility of examining both earlier response and persistence over time, although the registry does not report the results or the analysis used to summarize them.

The active video comparator is also important to the interpretation of any future comparison. The groups differ in video content, while both receive narrated educational material. A group contrast would therefore address the relative outcomes under these two video conditions, rather than the effect of receiving any video compared with receiving none.

The study’s stated focus on culturally relevant stories and African-American Veterans’ voices makes the intervention’s context central to the research question. At the same time, generalizing findings would require information about who enrolled, how participants were recruited, and whether the study population represents the settings in which the intervention might be considered. Those details are not reported in the registry record.

Finally, this record illustrates the distinction between a registered study design and an interpretable result. Randomization, endpoint definition, follow-up timing, and safety counts are useful information, but estimates and analysis details are needed to evaluate the primary comparison. Because those results are not reported in the registry record, the statistical importance lies in the question and measurement strategy rather than in a demonstrated treatment effect.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record leaves important design and analysis details unspecified. It does not report eligibility criteria, recruitment procedures, participant characteristics, or the demographic composition of enrollment. Although the stated objective focuses on African-Americans and the intervention description refers to African-American Veterans, the record does not establish the characteristics of all enrolled participants.

The primary adherence measure and assessment schedule are described, but the record does not define the precise handling of medication-monitoring data, device nonuse, or periods without usable measurements. It also does not report the number of participants with measurements at each visit or explain missing-data procedures. These omissions limit assessment of measurement quality and follow-up completeness.

Randomization is reported, but the sequence-generation and allocation-concealment methods are not. The study is listed as unmasked; the record does not explain how awareness of assignment was addressed in outcome collection or analysis. It also does not report the statistical analysis plan, the primary contrast across several assessment times, covariate adjustment, or analysis population.

The registry lists secondary outcomes but provides no outcome estimates, and it does not report how multiple outcomes or time points were handled. Detailed adverse-event definitions, ascertainment methods, event timing, and relatedness are also absent. Finally, enrollment is recorded as 306, but a trial-specific sample-size justification is not reported in the registry record. Taken together, these limitations prevent a full appraisal of outcome precision, missing-data risk, and the robustness of the intended comparison.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study — NCT02741700.
• Registry record last updated 2022-03-17; status last verified 2022-03.
• Results first posted 2022-02-23.
• 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

NCT02741700 is a completed, randomized, unmasked, parallel-group study sponsored by the VA Office of Research and Development. The registry lists enrollment as 306 and records study dates from 2017-05-31 to primary completion on 2020-12-31. Its primary outcome is medication adherence, measured as the percentage of days urate-lowering therapy was taken with Medication Event Monitoring System Caps at 3, 6, 9, and 12 months.

The intervention was a culturally relevant gout storytelling video; the comparison was a narrated video about management of another chronic condition. Secondary outcomes listed are gout flares, patient satisfaction, and target serum urate. The registry reports selected adverse-event and death counts but does not report primary or secondary outcome estimates, statistical analysis methods, missing-data handling, or analysis populations. The record therefore describes the study design and measures but does not permit evaluation of the primary outcome effect.