This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Using an Internet Study to Improve Adherence for Psoriasis Patients (NCT01802580), a randomized early/phase 1 study. The primary outcome is Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01802580 |
| Phase | EARLY/Phase 1 |
| Condition | Psoriasis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 40 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Wake Forest University |
| Results posted | Yes |
2. Clinical Question
Population
People with psoriasis whose condition was considered suitable for treatment with fluocinonide were eligible for the study. The registry describes enrollment of 40 participants. It does not report further eligibility details or characteristics of the participants contributing to the primary endpoint.
Intervention
The intervention was an Internet reminder survey alongside fluocinonide 0.05% ointment. The registry describes a treatment phase of 12 months. The primary question concerns whether adherence, measured using days on which the correct number of doses was taken, differed for participants assigned to this intervention.
Comparator
The comparator was standard care without the Internet survey. The registry describes standard psoriasis treatment with fluocinonide and use of an electronic monitoring cap. Full operational details for both arms are not reported in the registry record.
Primary question
The primary endpoint was the number of days with a correct number of doses taken, measured up to 12 months. The posted results give an arm-level mean of 15.14 days for the Internet reminder survey group and 20.22 days for the standard-care group. They do not report a formal estimate or test of the between-arm difference.
This is a question about a measured adherence outcome, not a direct comparison of all possible treatment outcomes for psoriasis. The registry also lists disease severity assessed with PASI and IGA, as well as mean days per week medication was taken, among secondary outcomes. The results available for the primary endpoint do not establish why participants took medication as they did, or whether adherence changed over time. Those details, along with the clinical interpretation of a particular difference in adherence, are not reported in the registry record.
3. Trial Design
The registry identifies a randomized, single-masked, parallel-group study of an Internet-based intervention for people with psoriasis. The study is marked completed, with enrollment of 40. The listed sponsor is Wake Forest University. The record classifies the study as EARLY PHASE1, while its study type is listed as other. These registry classifications describe how the study was registered; they do not supply additional information about its procedures.
Participants were assigned to an Internet reminder survey intervention or standard care without the Internet survey. Both descriptions concern treatment with fluocinonide, and the registry lists fluocinonide 0.05% ointment as a drug intervention and the Internet survey as a behavioral intervention. The intervention-arm description specifies a treatment phase of 12 months. The comparator description refers to standard treatment and an electronic monitoring cap. More complete details of what participants were asked to do, how often reminders were sent, and how masking was implemented are not reported in the registry record.
The registry lists study start as 2012-10 and primary completion as 2016-03. These dates do not by themselves describe the length of participation for each person. The primary endpoint timeframe is listed as up to 12 months, and the measure is based on days with a correct number of medication doses taken.
The posted primary endpoint results include 11 participants in the Internet reminder survey arm and 9 in the standard-care arm. The registry separately reports 20 participants at risk in each arm for adverse-event summaries. How these counts relate to enrollment, randomization, endpoint availability, or analysis populations is not reported in the registry record. Allocation concealment, the randomization procedure, the masking target, and protocol deviations are also 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
| Stage | Intervention - Internet Reminder Survey | Standard of Care, no Internet Survey |
|---|---|---|
| STARTED | 20 | 20 |
| COMPLETED | 11 | 9 |
| NOT COMPLETED | 9 | 11 |
Reasons for not completing this period:
| Reason | Intervention - Internet Reminder Survey | Standard of Care, no Internet Survey |
|---|---|---|
| Physician Decision | 1 | 0 |
| Protocol Violation | 2 | 0 |
| Withdrawal by Subject | 5 | 6 |
| Other | 1 | 3 |
| Lack of Efficacy | 0 | 2 |
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: Description of participants that completed study
| Characteristic | Unit | Intervention - Internet Reminder Survey | Standard of Care, no Internet Survey | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 9 | 20 | |
| Age, Continuous | years | 64.81 (50 to 77) | 58.67 (31 to 83) | 62.05 (31 to 83) |
| Sex: Female, Male: Female | Participants | 7 | 4 | 11 |
| Sex: Female, Male: Male | Participants | 4 | 5 | 9 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 11 | 9 | 20 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 1 | 3 |
| Race (NIH/OMB): White | Participants | 9 | 8 | 17 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken, measured over up to 12 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | Days |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of days on which a participant took the correct number of doses, measured up to 12 months. The registry describes this as a mean outcome in days and says that medication use was monitored with MEMS caps. In principle, an electronic monitoring measure can record patterns of container openings and provide a behavioral indicator of medication use. It does not, on its own, establish that medication was applied as directed or that a dose was absorbed.
The endpoint focuses on adherence rather than disease severity. That distinction matters: adherence is a measure of how medication is taken, while PASI and IGA are listed separately as secondary measures of psoriasis severity. The registry lists three secondary outcomes, including mean days per week medication was taken and disease severity measured with PASI and IGA. The relationship between the primary endpoint and the secondary adherence measure is not explained in the registry record.
The posted primary results are arm-level means: 15.14 days for the Internet reminder survey group and 20.22 days for the standard-care group. The reported full ranges are 0.27 to 33.42 and 3.125 to 53.3, respectively. The outcome counts are 11 and 9 participants. The registry does not report a between-arm effect estimate, confidence interval, or statistical test for this endpoint. It also does not explain the derivation of the ranges or how incomplete monitoring was handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted results describe the primary adherence measure separately by randomized arm. The mean number of days with a correct number of doses taken was 15.14 in the Internet reminder survey arm, based on 11 participants, and 20.22 in the standard-care arm, based on 9 participants. The reported full range was 0.27 to 33.42 in the intervention arm and 3.125 to 53.3 in the standard-care arm. These summaries show the values recorded in the registry; they do not provide a formal estimate of the difference between arms.
A mean gives a measure of the center of the observed values, while a range conveys the span from the lowest to highest reported values. A range does not show how observations are distributed within that span. It cannot establish whether most participants had similar outcomes or whether a small number of observations were far from the mean. The broad ranges indicate that the posted values varied within each group, but the registry record does not provide participant-level data or further distributional summaries.
No confidence interval, standard error, p-value, adjusted estimate, or test result for the primary between-arm comparison is reported in the registry record. Without an estimated contrast and its uncertainty, the arm means alone cannot determine how precisely the groups differ, or whether the observed difference is compatible with a wide range of underlying effects. A formal comparison would also need to account for the study’s analysis population and the way the endpoint was calculated; those details are not reported in the registry record.
The outcome counts for the primary endpoint are 11 and 9, while the registry lists enrollment of 40. This difference in reported counts does not reveal why fewer participants appear in the endpoint summaries. The registry record does not report whether this reflects missing endpoint data, exclusions, a defined analysis population, or another reason. The separate adverse-event summaries list 20 participants at risk in each arm, but those counts should not be assumed to define the primary endpoint population.
The result therefore supports a descriptive reading only: the registry reports arm-specific adherence means and ranges. It does not report a statistical conclusion about an intervention effect. The listed secondary outcomes include adherence frequency and psoriasis severity measures, but results or analyses for them are not reported in the registry record. Nor does the registry report a rationale for the observed endpoint values or a clinically meaningful threshold for interpreting them.
9. Statistical Methods Explained
The registry describes a randomized, single-masked, parallel-group study. Randomization is a design method intended to make treatment groups comparable, on average, with respect to both measured and unmeasured characteristics. It does not guarantee that groups will be balanced in a particular small study. The randomization method, allocation concealment, and details about who was masked are not reported in the registry record, so the implementation cannot be assessed from the record.
What does an arm-level mean show?
A mean condenses the observed outcome values within a group into one measure of their center. For this endpoint, the reported means are 15.14 days for the Internet reminder survey group and 20.22 days for standard care. A mean is useful for summarizing a group, but it does not describe every participant’s experience. It can also be influenced by unusually low or high observations. The registry labels the dispersion as full range and reports 0.27 to 33.42 for the intervention arm and 3.125 to 53.3 for standard care. A range gives the endpoints of the observed spread, not the distribution’s shape or typical variability around the mean.
Why is a confidence interval useful?
A confidence interval is a statistical way to express uncertainty around an estimated quantity, such as a mean or the contrast between two groups. It indicates which values are reasonably compatible with the data under the method used. A narrow interval indicates greater precision than a wide one, though interpretation also depends on the study design and analysis assumptions. No confidence interval for the between-arm comparison is reported in the registry record. The posted means and ranges are not substitutes for such an interval: a range describes observed values, whereas a confidence interval describes uncertainty in an estimate.
What can a hypothesis test add?
A statistical test evaluates how compatible the data are with a specified null hypothesis under a chosen model. A p-value, if reported, would not measure the probability that the null hypothesis is true, nor would it establish the size or practical importance of an effect. No p-value or primary comparison test is reported in the registry record. The analysis method, model specification, covariates, and handling of repeated observations are also not reported in the registry record. It is therefore not possible to reconstruct a sponsor-reported analysis from these summary statistics.
Why does the endpoint definition matter?
The endpoint is described as the number of days with a correct number of doses taken, recorded using MEMS caps, with a timeframe of up to 12 months. A count-based adherence outcome depends on the definition of a correct dosing day, the observation window, and the treatment regimen. Those operational definitions are not fully reported in the registry record. Electronic monitoring can capture a recorded event, but an event is not necessarily proof that medication was applied or used correctly. The registry does not report how device interruptions, missing monitoring records, or deviations from the regimen were handled.
What do planning illustrations mean?
Sample-size planning asks how many participants would be needed under specified assumptions to detect a chosen effect with a chosen statistical procedure. Such calculations depend on assumptions about the effect, variability, significance level, allocation, and analysis. The registry record does not report the trial’s own sample-size justification. Any planning illustrations associated with these results are based on the observed effect and stated assumptions, not on evidence that the study had a particular probability of finding an effect. They are planning scenarios, not observed power and not a substitute for the missing comparison estimate.
The stated illustration assumptions include a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects defined as fractions of the observed effect. These are assumptions for a planning exercise and should not be read as confirmed features of the original protocol. The registry record does not report that those assumptions were used to design or analyze this trial.
What does over-dispersion mean in general?
For count outcomes, a statistical model may assume a particular relationship between the mean and variability. Over-dispersion occurs when observed variability is greater than the model assumes. If not addressed, standard errors and uncertainty estimates can be misleading. This is a general consideration for count data, not a finding established by the posted summaries. The registry does not provide enough information to assess whether a count model was used or whether over-dispersion was present.
More broadly, statistical interpretation requires the outcome definition, the analysis population, a prespecified comparison, and methods for uncertainty and missing data. Several of those elements are not reported in the registry record. The arm-level results can be described, but additional inferential claims cannot be recovered from the posted means and ranges alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three secondary outcomes: mean days per week medication was taken, disease severity with PASI, and disease severity with IGA assessment. It reports four outcome measures in total, but no analyses are listed. Results for the secondary outcomes and the relationship between those outcomes and the primary endpoint are not reported in the registry record.
When a study examines multiple outcomes or multiple comparisons, the chance of obtaining at least one apparently notable result can increase. Statistical methods for handling multiplicity can include prespecifying a primary outcome, adjusting significance thresholds, or treating additional analyses as exploratory. Which approach was planned or used in this trial is not reported in the registry record. The existence of several listed outcomes does not, by itself, show that a multiplicity adjustment was required or performed.
The primary endpoint results include 11 participants in the Internet reminder survey arm and 9 in standard care. The registry lists enrollment of 40, but does not explain the relationship between enrollment and these endpoint counts. It does not report the number of missing endpoint observations, reasons for missingness, imputation methods, or sensitivity analyses. The registry also does not report whether the primary analysis used an intention-to-treat population, a per-protocol population, or another analysis population.
Missing data can affect estimates when the availability of an outcome is related to participant characteristics or outcomes. Without information on completeness and handling, it is not possible to assess whether the reported summaries represent all randomized participants or a subset. The adverse-event risk counts do not resolve this uncertainty about the primary endpoint population. The registry record does not report an analysis plan or protocol details that would clarify these issues.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Intervention - Internet Reminder Survey | 0 | 20 | 0.0% |
| Standard of Care, no Internet Survey | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention - Internet Reminder Survey | 0 of 20 |
| Standard of Care, no Internet Survey | 0 of 20 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Intervention - Internet Reminder Survey | 1 of 20 |
| Standard of Care, no Internet Survey | 1 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Intervention - Internet Reminder Survey | Standard of Care, no Internet Survey |
|---|---|---|---|
| Fungal Infection | Skin and subcutaneous tissue disorders | 1 of 20 | 0 of 20 |
| Burning Sensation | Skin and subcutaneous tissue disorders | 0 of 20 | 1 of 20 |
The adverse-event summary lists 20 participants at risk in each arm. It reports zero participants with a serious adverse event in the Internet reminder survey arm and zero in standard care. It lists one participant with an other adverse event in each arm, and zero deaths in each arm. No serious adverse-event terms are listed.
These are registry counts, not a complete narrative of every event or an assessment of causality. The category labelled other adverse events is distinct from the serious-adverse-event count. The record does not provide event descriptions, severity details for the other events, timing, duration, or investigator assessments of whether events were related to the intervention or medication. The listed risk counts should not be assumed to be the same participants as those represented in the primary endpoint summaries.
Zero recorded serious adverse events means that the registry summary reports none in the listed groups; it does not establish that no event could occur or resolve the safety of treatment. The registry record does not report additional safety analyses or explain whether events were collected over the same timeframe as the primary endpoint.
12. What the Result Does, and Does Not, Mean
The posted primary results are descriptive arm-level summaries of days with a correct number of doses taken. The Internet reminder survey group has a reported mean of 15.14 days, with a full range of 0.27 to 33.42. The standard-care group has a reported mean of 20.22 days, with a full range of 3.125 to 53.3. These figures describe the participants included in each summary, whose counts are 11 and 9, respectively.
They do not, by themselves, show whether the intervention caused a change in adherence. A causal interpretation depends on the conduct of randomization, complete outcome measurement, the analysis population, and a suitable comparison analysis. Although the trial is registered as randomized, important details about these elements are not reported in the registry record. There is no reported between-arm estimate with an uncertainty interval or statistical test for the primary endpoint.
The posted results also do not establish whether any difference in adherence would be clinically important. The registry does not report a threshold for meaningful change, nor does it report how the adherence measure relates to disease severity or other patient outcomes. PASI and IGA appear among the secondary outcomes, but their results are not reported in the registry record.
The enrollment count of 40 and the endpoint counts of 11 and 9 are distinct reported figures. The record does not explain the difference, so it cannot be attributed to missingness, exclusions, or any particular analysis choice. The adverse-event summaries have separate risk counts and should be interpreted within their own reported scope.
In short, the registry reports arm-specific adherence summaries and adverse-event counts, but it does not report the statistical comparison needed to quantify the intervention effect. The result should not be interpreted as a treatment recommendation or as proof for or against an effect. It is a limited description of the posted outcomes, with important inferential and data-handling details not reported in the registry record.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between recording medication-taking behavior and evaluating an intervention effect. The primary outcome uses electronic monitoring to summarize days with a correct number of doses taken. Such measures can generate detailed adherence information, but a summary still depends on clear definitions of the dosing event, the observation period, and how monitoring gaps are treated. The registry record does not report all of those details.
The randomized parallel-group design is relevant because a comparison between assigned groups can, under suitable conditions, help estimate an intervention effect. Yet randomization alone is not enough to interpret the reported arm means as an effect estimate. The posted results do not include a formal between-arm contrast or its uncertainty, and they do not explain the relationship between the endpoint counts and total enrollment. This makes it important to distinguish descriptive results from inferential conclusions.
The small numbers of participants appearing in the primary summaries also focus attention on precision and missing-data reporting. A mean can be calculated for a group without revealing how precisely it estimates the underlying average. Ranges show the span of recorded values but do not answer that precision question. Confidence intervals, analysis details, and clear participant flow would help readers assess uncertainty, but these are not reported in the registry record.
Finally, adherence and disease severity are different outcome domains. The registry lists both, but results for the secondary severity outcomes are not reported. Keeping these domains distinct prevents an adherence measure from being treated as a direct measure of psoriasis response. The record illustrates why trial interpretation depends not only on the outcome values, but also on transparent definitions, analysis methods, missing-data accounting, and reporting of uncertainty.
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.
Several trial-specific details needed to interpret the results are not reported in the registry record. The primary endpoint definition gives a measure and timeframe, but does not fully explain how a correct dosing day was determined, how the monitoring cap data were processed, or how incomplete monitoring was handled. The outcome counts of 11 and 9 are smaller than the listed enrollment of 40, but the record does not explain why or identify the analysis population.
The registry reports arm means and full ranges, but no primary comparison estimate, confidence interval, or test. It does not report the analysis model, covariate adjustment, prespecified hypotheses, sample-size justification, or protocol analysis plan. Consequently, the posted summaries do not support a precise estimate of the between-arm effect or an assessment of its uncertainty.
The description of the Internet intervention is incomplete in the registry record. The record identifies an Internet reminder survey and gives a 12-month treatment phase, but the reminder schedule, survey content, participant engagement, and adherence to the intervention are not fully described. The degree and target of single masking are also not reported. These omissions limit assessment of how the intervention was delivered and whether participants or outcome assessors could have been influenced by assignment.
Three secondary outcomes are listed, but their results and analyses are not reported in the registry record. Multiplicity procedures, missing-data methods, and the handling of protocol deviations are also not reported. Safety summaries provide counts but no event descriptions or detailed follow-up context. Together, these reporting gaps restrict interpretation to the descriptive results and counts recorded for the study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Using an Internet Study to Improve Adherence for Psoriasis Patients — NCT01802580.
- Registry record last updated 2020-06-04; status last verified 2020-05.
- Results first posted 2019-11-12.
- 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.
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18. Record Summary
This completed randomized, single-masked, parallel-group study evaluated an Internet reminder survey in people with psoriasis receiving fluocinonide. The registry reports enrollment of 40 and a primary endpoint measuring days with a correct number of doses taken, up to 12 months. The mean was 15.14 days among 11 participants in the intervention arm and 20.22 days among 9 participants in standard care; full ranges were 0.27 to 33.42 and 3.125 to 53.3, respectively.
No formal between-arm analysis is reported in the registry record. The relationship between the endpoint counts and enrollment, the analysis population, missing-data methods, and the trial’s statistical plan are not reported. Safety summaries list zero serious adverse events and zero deaths in each arm, with one other adverse event in each. Three secondary outcomes are registered, but their results are not reported.