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 Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease (NCT01860651), a randomized na study. The primary outcome is Medical Adherence.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01860651 |
| Phase | NA |
| Condition | Inflammatory Bowel Disease, Ulcerative Colitis, Crohn´s Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 103 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Hvidovre University Hospital |
| Results posted | Yes |
2. Clinical Question
Population
The project concerns young patients with inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. The registry summary describes the intended young-patient group as ages 10-17. The primary endpoint population was narrower: participants in the study group taking medication at home. The registry record reports 27 participants in the web-monitoring group and 26 in the control group for that endpoint.
Intervention
Web-monitoring was the behavioral intervention. The registry describes a web program and app that presented disease activity using a traffic-light chart and guided participants toward continuing prescribed medication, contacting a physician, or visiting the outpatient clinic. The record describes intervention participants receiving either home-administered medication or biological treatment; it does not explain how these categories were handled in the primary endpoint comparison.
Comparator
The comparator was control care. For participants taking medication at home, the control description specifies routine outpatient controls four times a year. For participants receiving biologicals, the control description refers to a retrospective routine treatment algorithm. The primary endpoint results, however, concern the home-medication group only.
Primary question
The primary question was whether medical adherence, measured with the Medicine Adherence Report Scale, differed over time between web-monitoring and control among participants taking medication at home. The registry reports mean scores summarized across the study period and a mixed effect model estimate of the mean difference over time. The posted result is an estimate with a confidence interval and p-value; it is not, by itself, a determination of clinical importance or proof of a causal mechanism.
3. Trial Design
The study was registered as randomized, with a parallel-group model and no masking. It was sponsored by Hvidovre University Hospital and is recorded as completed. The registry lists an enrollment of 103. The recorded phase is NA. The trial began in 2013-09, with primary completion in 2017-05.
The intervention was web-monitoring, described as an e-health program and app for presenting disease activity and guiding patients’ next steps. The control description varies by treatment category: routine outpatient controls for participants taking medication at home, and a retrospective routine treatment algorithm for participants receiving biologicals. The registry describes two intervention treatment categories but does not report a detailed allocation procedure for these categories.
The primary endpoint comparison includes only participants taking medication at home: 27 in the web-monitoring group and 26 in the control group. Thus, although the overall enrollment was 103, the primary outcome data apply to this stated subgroup, not necessarily to every enrolled participant or treatment category. The registry record does not report the randomization sequence method, allocation concealment, or the allocation ratio.
The primary outcome was assessed prospectively at each third month, up to 2 years. The record also lists secondary outcomes concerning step up in medical intensity, surgery, absence from school, hospital contact, and weeks between treatment. It reports six outcome measures and one analysis overall, while five secondary outcomes are listed. The timing and available results differ across those outcomes. Detailed protocol information, including a full statistical analysis plan and the explanation for the enrollment target, is 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 | Web-monitoring | Control |
|---|---|---|
| STARTED | 56 | 47 |
| COMPLETED | 31 | 39 |
| NOT COMPLETED | 25 | 8 |
Analysis population for the primary outcome, as defined in the registry: Number of participants is only from study 1) Patients in treatment with medicine adminstered at home (participant in the web-group: 27; participant in the control-group: 26)
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.
| Characteristic | Unit | Web-monitoring | Control | Total |
|---|---|---|---|---|
| Participants analysed | 56 | 47 | 103 | |
| Age, Categorical: <=18 years | Participants | 56 | 47 | 103 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 15.1 (SD 1.82) | 14.7 (SD 2.11) | 14.9 (SD 0.2) |
| Sex: Female, Male: Female | Participants | 31 | 22 | 53 |
| Sex: Female, Male: Male | Participants | 25 | 25 | 50 |
| 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 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 56 | 47 | 103 |
| Region of Enrollment: Denmark | participants | 56 | 47 | 103 |
6. Primary Endpoint
The registry lists the primary outcome as Medical Adherence, measured over Prospective, each third month, up to 2 years.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is medical adherence, measured with the Medicine Adherence Report Scale (MARS) among participants taking medication at home. The scale ranges from 5-25 points, and higher scores indicate a better outcome. The registry describes prospective measurement at each third month, up to 2 years, and reports group means summarized over the whole study period.
Adherence is relevant to this study because the registry summary identifies taking prescribed medicine as a challenge for young patients. The measure therefore focuses on a treatment behavior that the web-monitoring intervention was intended to support. It is a scale-based endpoint, rather than a direct measure of disease activity or quality of life; the registry’s stated hypothesis about disease course and quality of life does not make those the primary endpoint.
For the primary results, the mean MARS score was 23.3 in each group. The confidence interval was 22.9 to 23.6 for web-monitoring and 22.9 to 23.7 for control. The reported model estimates the mean difference over time rather than only a single end-of-study contrast. The registry does not report a threshold for a clinically important MARS difference, nor does it state how missing repeated measurements were handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary summaries show a mean MARS score of 23.3 in both groups. The 95% confidence intervals are 22.9 to 23.6 for web-monitoring and 22.9 to 23.7 for control. These descriptive summaries are close, but the model-based analysis is the more direct reported comparison over time: it estimates a mean difference of -0.002, with a 95% confidence interval from -0.005 to 0.001 and p = 0.22.
The estimate is close to zero on the MARS scale, and its confidence interval includes zero. In general, a confidence interval describes the range of effect values compatible with the data and the model at the stated confidence level; it is not a guarantee that the true effect lies within that range. The model result does not establish a difference between groups at conventional statistical thresholds. Nor does the p-value establish that the groups are equivalent: equivalence would require a prespecified margin and an analysis designed for that question, neither of which is reported in the registry record.
The group means are reported as summaries across the study period, while the mixed effect model result is explicitly described as a mean difference over time. These are related but not identical summaries. The model result incorporates a longitudinal comparison, whereas the separate mean and confidence intervals do not show the trajectory of individual participants or the timing of any changes. The registry record does not give model specifications, such as the covariance structure or the variables included in the model.
The primary endpoint population was participants taking medication at home, with 27 in the web-monitoring group and 26 in control. It should not be assumed that this result represents all 103 enrolled participants or those receiving biologicals. The registry’s broader project description also mentions disease activity, treatment responsibility, and quality of life, but the primary result presented is about adherence scores in the home-medication subgroup.
The result is therefore best read as a model-based estimate that is near zero and imprecise enough to include small values on either side of zero. It is not evidence that web-monitoring did or did not change disease course, quality of life, or other clinical outcomes. No clinically important difference threshold, missing-data strategy, or analysis-population definition is reported in the registry record, limiting how far the numerical result can be interpreted.
9. Statistical Methods Explained
The primary analysis is identified as a mixed effect model, with the reported parameter described as the mean difference over time. In general, mixed effect models are used for data with repeated observations, such as measurements from the same participant at multiple times. They can represent both group-level patterns and the fact that measurements from one participant are related to each other. The registry says that adherence was assessed prospectively at each third month, up to 2 years, so a longitudinal model is consistent with the repeated-measure structure described. The exact model specification is not reported in the registry record.
What does the reported mean difference represent?
The posted model estimate is -0.002 for the mean difference over time, with a 95% confidence interval from -0.005 to 0.001 and p = 0.22. The estimate describes the modeled contrast between web-monitoring and control over the observation period; it is not the same quantity as subtracting the two displayed group means at one particular visit. The registry does not specify the time coding, whether the difference is constant across follow-up, or whether an interaction between group and time was fitted. Those details matter for understanding the exact interpretation of a longitudinal contrast.
A confidence interval conveys uncertainty around an estimated effect under the assumptions of the analysis. An interval that includes zero is compatible with no difference, but it may also be compatible with small differences in either direction. Statistical nonsignificance is not proof of equivalence or absence of effect. Demonstrating equivalence requires a clinically justified margin set in advance and a method designed to assess whether the interval falls within that margin. Such a margin and equivalence analysis are not reported in the registry record.
How should the descriptive summaries be read?
The posted means are 23.3 for web-monitoring and 23.3 for control. Their respective 95% confidence intervals are 22.9 to 23.6 and 22.9 to 23.7. They summarize the groups over the whole study period, as described in the endpoint record. A confidence interval for each group mean addresses uncertainty in that mean; it is not a substitute for the interval on the between-group model estimate. Overlap between two separate mean intervals is also not itself the formal test of a group difference. The mixed effect model’s contrast is the reported inferential comparison.
What is the role of the recalculated secondary comparisons?
The secondary comparisons are simple, unadjusted recalculations from posted summary statistics, rather than sponsor-reported comparative analyses. Such calculations can help describe the observed summaries, but they do not recreate analyses of participant-level data or account for covariates, repeated measurements, or other design features unless those are specifically included. The registry lists no reported analyses for the secondary endpoints. Their unadjusted p-values should therefore be treated as exploratory, particularly because several outcomes are listed and no multiplicity procedure is reported.
General statistical context: multiple comparisons create more opportunities for results to appear unusual by chance. Adjustments or a prespecified hierarchy can help control how those comparisons are interpreted. The registry record does not report such a plan. Consequently, secondary findings should not be treated as confirmatory evidence solely because an unadjusted p-value is small.
What do the planning illustrations mean?
The planning illustrations are based on observed effects and stated assumptions, not on the trial’s own design. The assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect set to a stated fraction of the observed effect. These are hypothetical planning scenarios. They do not measure the probability that this completed trial detected an effect, and they are not observed power. An observed effect can be unstable, especially when based on limited data, so planning based directly on it should be treated cautiously.
In general, planning estimates depend on the target effect, variability, statistical method, and design assumptions. A smaller target effect typically requires more participants for the same planned power, all else being equal; that is a general statistical relationship, not a new result about this study. The registry does not report the trial’s original sample-size justification, target effect, or planning assumptions. The posted illustrations cannot be used to infer what the investigators planned before the study began.
Other important method details are also not reported in the registry record. These include the handling of missing observations, the analysis population, the treatment of protocol deviations, and whether any interim analyses were conducted. Without those details, the posted estimate can be described, but it cannot be fully audited against a prespecified analysis plan.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Mixed Effect Model | mean difference over time -0.002 | -0.005 to 0.001 | 0.220 |
The registry reports a sponsor analysis using a mixed effect model. Its estimate is a mean difference over time of -0.002, with a 95% confidence interval from -0.005 to 0.001 and p = 0.22. The sponsor’s analysis is the trial’s reported inferential result and takes precedence over simple recalculations from summary statistics.
A recalculation based on posted summaries would be unadjusted and would not reproduce the mixed effect model’s repeated-measure analysis. The registry does not provide enough model detail or participant-level data to independently reconstruct that analysis. Therefore, any simple recalculation should be regarded as a separate descriptive check, not as a correction or replacement for the sponsor result. The reported group means, both 23.3, are consistent with the model estimate being close to zero, but they do not explain the model’s assumptions or establish that the groups are equivalent.
The registry does not report a discrepancy between the sponsor analysis and the simple summaries. The model result should be read with its confidence interval and p-value, while recognizing that the analysis population is the home-medication subgroup and that important details about missing data and model specification are not reported in the registry record.
11. Multiplicity, Missing Data and Analysis Populations
The registry record lists several secondary outcomes in addition to the primary adherence endpoint. It does not report a multiplicity strategy, such as a hierarchy among outcomes or an adjustment to account for testing multiple hypotheses. In general, the more comparisons examined, the greater the chance that at least one result will appear statistically notable by chance alone. This is why unadjusted secondary comparisons usually warrant more caution than a prespecified primary analysis. The registry lists no sponsor-reported analyses for the secondary endpoints.
Missing-data methods are not reported in the registry record. For a repeated outcome measured prospectively over time, missing observations can matter if participants do not provide all scheduled measurements. Different assumptions about why data are missing and how to handle incomplete follow-up can affect estimates and uncertainty. The registry does not state how many MARS observations were available at each time, whether all participants contributed repeated measurements, or whether any imputation or sensitivity analysis was used.
The analysis populations are not fully described. The primary endpoint population is explicitly restricted to participants taking medication at home, with 27 in web-monitoring and 26 in control. The registry does not report whether this is an intention-to-treat population, a per-protocol population, or another defined analysis set. It also does not explain the treatment of participants who changed treatment category, withdrew, or did not complete follow-up.
Other protocol and analysis details are not reported in the registry record, including the original sample-size justification, randomization method, allocation concealment, interim analyses, and a full statistical analysis plan. Their absence does not determine that a particular method was or was not used; it means the registry entry does not document it. These limitations constrain assessment of prespecification, risk of bias, and the robustness of the posted estimates.
12. 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 |
|---|---|---|---|
| Web-monitoring | 0 | 56 | 0.0% |
| Control | 0 | 26 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Web-monitoring | 0 of 56 |
| Control | 0 of 47 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Web-monitoring | 3 of 29 |
| Control | 0 of 0 |
Most frequent serious adverse event terms
| Event term | Organ system | Web-monitoring | Control |
|---|---|---|---|
| Serious adverse event | Immune system disorders | 0 of 27 | 0 of 26 |
| serious adverse events | Immune system disorders | 0 of 29 | 0 of 0 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Web-monitoring | Control |
|---|---|---|---|
| Infusion-related allergic reactions | Immune system disorders | 3 of 29 | 0 of 0 |
Serious events with the highest arm-level rate: serious adverse event (0.0%), serious adverse events (0.0%).
The adverse-event record lists no serious adverse events among 56 at risk in the web-monitoring group and no serious adverse events among 26 at risk in control. It also lists zero deaths in each group. The serious-event terms are recorded as 0.0% for both displayed terms. These figures describe what was posted for the stated at-risk groups; they should not be confused with the primary endpoint population counts.
For other adverse events, the registry lists 3 affected among 29 at risk in web-monitoring and 0 affected among 0 at risk in control. The control entry therefore does not provide an at-risk group for that category, so it cannot support a balanced comparison of other adverse events. The registry does not give additional detail about event types, severity, timing, or the way adverse events were collected.
A zero count in a posted group does not by itself establish that an event is impossible or that a treatment is safe. In general, safety interpretation depends on the number observed, the number followed, how events were defined and collected, and the duration of observation. These figures are descriptive registry entries, not a complete safety assessment.
13. What the Result Does, and Does Not, Mean
The primary result is a comparison of medical-adherence scores over time among participants taking medication at home. The posted group means are both 23.3, and the mixed effect model estimates a mean difference over time of -0.002. Its 95% confidence interval ranges from -0.005 to 0.001, with p = 0.22. The estimate is close to zero, and the interval includes zero.
This result does not establish that web-monitoring and control are equivalent. A nonsignificant test is not an equivalence test, and the registry does not report a clinically important difference threshold or a prespecified equivalence margin. It also does not establish that there is no effect; the confidence interval expresses uncertainty and remains the appropriate context for the estimate.
The endpoint is adherence on the MARS scale, whose range is 5-25 points and whose higher scores indicate a better outcome. It is not a direct measure of disease activity, quality of life, surgery, school attendance, or hospital use. The project summary describes hopes about disease course and quality of life, but those broad aims should not be substituted for the primary endpoint result.
The result applies to the stated home-medication subgroup, not automatically to all participants in the enrolled study or those receiving biologicals. The registry record does not report enough detail to assess missing observations, the analysis population beyond the endpoint description, or all model assumptions. The finding should therefore be interpreted as the posted estimate for this specific outcome and population, with the stated uncertainty and reporting limitations. It does not provide medical advice or establish that the intervention works or does not work.
14. Why This Trial Matters Statistically
This trial is statistically informative because it distinguishes a project’s broad rationale from the outcome actually tested. The registry summary describes an intervention intended to support young patients’ responsibility for treatment and adherence, with hoped-for implications for disease course and quality of life. The primary endpoint, however, is a defined adherence scale measured repeatedly among participants taking medication at home. Keeping those claims separate prevents a result on one construct from being generalized to outcomes that were not measured as the primary endpoint.
The registry also illustrates why longitudinal estimates and simple group summaries should not be treated as identical. The displayed mean MARS scores are 23.3 in both groups, while the reported mixed effect model estimates a mean difference over time. A model-based estimate uses a specified analytic approach to repeated measurements, though the exact specification is not reported. The interval around the estimate is essential for understanding its precision; the p-value alone is not a complete account.
Another statistical lesson is the distinction between confirmatory and exploratory results. One primary endpoint is identified, while several secondary outcomes are listed. Without a reported multiplicity plan, secondary comparisons deserve cautious interpretation. Likewise, planning illustrations based on observed effects are not evidence of the trial’s original design or observed power. The registry does not report its original sample-size justification.
Finally, transparent interpretation depends not only on effect estimates but also on populations, missing data, model details, and safety denominators. Several of these elements are not reported in the registry record. Recognizing those limits is part of drawing appropriately bounded conclusions from clinical trial results.
15. 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 population is limited to participants taking medication at home, with 27 participants in web-monitoring and 26 in control. The registry’s overall enrollment is 103, but the primary result should not be generalized to every enrolled participant without additional information about the other treatment category and its outcomes. The record describes participants receiving biologicals in the study arms, but does not report a corresponding primary adherence result for them.
The registry does not describe how participants were randomized, whether allocation was concealed, or how randomization was implemented across the treatment categories. Masking is recorded as none. These entries leave important details about potential sources of bias undocumented. The description of control care also differs by treatment category, which complicates interpreting the study as a single uniform comparison.
The mixed effect model is named, but its specification is not reported. The record does not explain the time structure, covariance assumptions, model terms, or handling of missing repeated measurements. It does not provide a clinically important MARS difference threshold. Therefore, the practical meaning of the small model estimate cannot be assessed against a stated threshold, and the precision of the result should be considered alongside the incomplete methods detail.
Five secondary outcomes are listed, with no reported sponsor analyses for them and no multiplicity plan documented. Their comparisons are unadjusted recalculations and should not be treated as confirmatory. The registry also does not report the original sample-size justification, interim analyses, or a complete statistical analysis plan. These limitations do not dictate the direction of any effect, but they restrict assessment of the analysis and the strength of claims that can be made from the posted record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Web-based Monitoring in Children and Adolescents With Inflammatory Bowel Disease — NCT01860651.
- Registry record last updated 2019-03-01; status last verified 2018-08.
- Results first posted 2019-02-15.
- 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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19. Record Summary
NCT01860651 is a completed randomized, parallel-group trial of web-based monitoring in children and adolescents with inflammatory bowel disease. It lists Hvidovre University Hospital as sponsor, enrollment of 103, no masking, and phase NA. The recorded study dates are 2013-09 to primary completion in 2017-05.
The primary endpoint was medical adherence measured with the MARS scale among participants taking medication at home. The group means were 23.3 in both arms. The reported mixed effect model estimate for mean difference over time was -0.002, with a 95% confidence interval from -0.005 to 0.001 and p = 0.22.
The record lists secondary outcomes spanning treatment intensity, surgery, school absence, hospital contact, and time between treatment. Details on missing-data handling, the full statistical plan, multiplicity, and several other design features are not reported in the registry record. The primary result is specific to the stated subgroup and endpoint.