Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia (NCT03004911), a randomized na study. The primary outcome is Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire.

2. Clinical Question

The study was designed to test the application in comparison with a booklet, not against no intervention. The principal outcome is a score on a scale from 0 to 100, with higher scores indicating a worse outcome. The registry record also names secondary measures of painful areas, pain, symptom severity, self-care agency, and use of application functions. Numerical results are posted for some of these outcomes.

This is a short-term comparison of two approaches to supporting self-care. The primary question concerns the groups' outcome scores at the recorded follow-up, rather than whether either approach changed participants' scores from a baseline value. Baseline outcome values and a description of a baseline-adjusted analysis are not reported in the registry record.

3. Trial Design

The registry record describes a randomized, single-masked, parallel-group study, marked completed. The listed phase is NA. Enrollment was 40, and the primary outcome results include 20 participants in each group. Randomization means that assignment was intended to be determined by chance; details of sequence generation, concealment, and implementation are not reported in the registry record.

The two groups received the ProFibro mobile application or a paper booklet. The record identifies both interventions as devices but does not further describe their content, how participants used them, or whether other care was permitted. Although masking is recorded as single, whose knowledge of assignment was masked is not reported in the registry record. The record also does not state whether outcome assessors or analysts were masked.

The primary outcome was assessed at 6 weeks. The study summary describes the purpose as testing the application’s efficacy for promoting self-care and improving symptoms and health-related quality of life in Brazilian patients with fibromyalgia. The primary result concerns health-related quality of life; secondary outcomes include measures of pain, symptom severity, painful areas, self-care agency, and application use.

The registry record lists a start date of 2017-02-14 and a primary completion date of 2017-12-12. It names University of Sao Paulo General Hospital as the sponsor. The original protocol’s sample-size rationale, planned analysis populations, handling of missing data, and further design details 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

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 Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire, measured over 6 weeks.

The primary endpoint is health-related quality of life assessed with the Revised Fibromyalgia Impact Questionnaire. The registry describes the outcome as a score on a scale with a minimum value of 0 and a maximum value of 100. Higher scores mean worse outcome. Results are reported as group means with standard deviations.

A questionnaire score provides a numerical way to compare participants’ reported impact of fibromyalgia across groups. The measure is relevant to the study’s stated aim because the summary identifies health-related quality of life as an outcome the application is intended to address. Comparing the scores at 6 weeks gives a snapshot of the groups at that follow-up. The record does not report baseline scores or describe a change-from-baseline primary analysis.

Interpretation must retain the direction of the scale: a lower score corresponds to a better outcome according to the registry description. The mobile application group’s mean was 53.7, while the paper booklet group’s mean was 55.5. These are group averages, not descriptions of every participant’s score. The standard deviations indicate variability among the scores within each group; they are not confidence intervals for the group means.

The Revised Fibromyalgia Impact Questionnaire is the named primary measure, but details about its administration, scoring procedures beyond the stated range and direction, or the definition of a meaningful difference are not reported in the registry record.

7. Results Posted in the Registry

• Paper Booklet: mean 55.50 versus 53.70 on control; difference 1.80 (95% CI -9.14 to 12.74), standardized effect d = 0.10; z-test p = 0.747.

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.

Number of Painful Areas Assessed With the Widespread Pain Index

• 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:
  • Paper Booklet: mean 12.30 versus 12.50 on control; difference -0.20 (95% CI -3.02 to 2.62), standardized effect d = -0.04; z-test p = 0.889.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Paper Booklet and the control. The interval gives the range of effects that remain compatible with the data.

Pain Assessed With the Visual Analogue Scale

• 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:
  • Paper Booklet: mean 5.30 versus 5.10 on control; difference 0.20 (95% CI -1.32 to 1.72), standardized effect d = 0.08; z-test p = 0.797.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Paper Booklet and the control. The interval gives the range of effects that remain compatible with the data.

Severity of Symptoms Assessed With the Symptom Severity Scale

• 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:
  • Paper Booklet: mean 7.60 versus 7.60 on control; difference 0.00 (95% CI -1.65 to 1.65), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Paper Booklet and the control. The interval gives the range of effects that remain compatible with the data.

The numerical secondary results available for painful areas, pain, and symptom severity show group means that are close to one another, with comparison intervals that include zero. Taken together, these results do not present a pattern of clear separation between the mobile application and paper booklet groups across the posted measures. They provide context for the primary result, whose group means and interval likewise do not establish a clear difference at 6 weeks.

The registry record names five secondary outcomes, including measures of self-care agency and adherence assessed through application clicks. Numerical results are posted for three secondary outcomes; results for the other named secondary outcomes are not reported in the registry record. The absence of posted numerical results for those measures means they cannot be used to confirm or qualify the observed pattern.

Secondary endpoints are useful for describing additional dimensions of the study’s aims, but they should generally carry less weight than the prespecified primary endpoint. Considering many outcomes creates more opportunities for apparently notable findings to arise by chance. Whether and how the analysis accounted for multiple comparisons is not reported in the registry record. The posted secondary p-values are unadjusted, so they should not be treated as independent confirmation of a treatment effect.

Nor should similar group averages be taken as proof that every aspect of the interventions performed alike. The results concern the measured outcomes, recorded at the stated timeframe, and do not resolve unreported endpoints or establish equivalence. Overall, the secondary outcomes provide a broad but incomplete picture and do not overturn the cautious interpretation of the primary result.

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

• Number of Painful Areas Assessed With the Widespread Pain Index
• Pain Assessed With the Visual Analogue Scale
• Severity of Symptoms Assessed With the Symptom Severity Scale
• Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised
• Adherence to Mobile Application Assessed by Number of Clicks on the App Functions

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant has a score, and the registry reports a mean and standard deviation for each group. A mean describes the center of the observed scores. A standard deviation describes how dispersed individual scores are around that group’s mean. Neither statistic alone describes how precisely the difference between group means has been estimated.

The posted comparison is a mean difference between the paper booklet and mobile application groups. Its direction is paper booklet minus mobile application. This makes a positive difference correspond to a higher, and therefore worse, average score in the paper booklet group under the registry’s scoring description. The primary estimate is 1.8. Direction matters: interpreting the number without knowing which group was subtracted from which can reverse the conclusion about which group had the higher mean.

The sponsor’s reported method is a two-sided t-test. In general, a t-test assesses whether an observed difference between group means is large relative to its estimated sampling uncertainty, under the method’s assumptions. A two-sided test considers differences in either direction rather than specifying only one direction. The reported p-value is 0.740. A recalculation using the posted group summaries gives an unadjusted p-value of 0.747. These values are evidence measures for the observed comparison, not probabilities that either treatment is effective or ineffective.

A p-value describes how unusual data at least as discrepant as the observed data would be under a specified null model and analysis assumptions. It does not measure the size of a difference, and it does not give the probability that the null hypothesis is true. A p-value should be read alongside the estimated difference and its confidence interval. Here, the interval spans negative and positive differences, which signals substantial uncertainty about the direction and size of the group contrast.

What does the confidence interval add?

A confidence interval expresses uncertainty about an estimated quantity through a range of values compatible with the data and the interval procedure. The reported interval for the primary mean difference runs from -9.145 to 12.74. It includes zero, which corresponds to no difference in group means, and includes differences favoring either group. It therefore conveys more than a single point estimate. The confidence level used for the posted interval is not reported in the registry record, so it should not be assigned a particular nominal level based on the available information.

The interval’s width is relevant to precision. An estimate close to zero can be paired with a narrow interval or a wide one; those cases do not convey the same information. In this comparison, the interval allows a substantial range of possible differences relative to the scale. The registry does not state what size of difference would be important to patients or researchers, so statistical uncertainty cannot be translated into a judgment about clinical importance.

Why does variability matter?

Participant scores vary within each group. Greater variability generally makes it harder to estimate a group contrast precisely when other features are held constant. The standard deviations in the registry describe this within-group spread. In a general comparison of means, standard errors quantify uncertainty in estimates and depend on both variability and the amount of information available. The posted summaries include standard errors for each group, but a group standard error is not itself the uncertainty interval for the between-group difference.

Over-dispersion is a general concern when data vary more than a statistical model expects: standard errors can then be too small, and intervals too narrow, if the analysis does not account for the extra variation. The primary outcome is a continuous score analyzed with a t-test, and the registry record does not report an over-dispersion assessment. It also does not report diagnostic checks for the t-test assumptions, such as the distributional behavior of scores or the handling of unequal variances. These details should not be inferred from the reported test alone.

What does randomization contribute?

Random assignment is intended to make treatment groups comparable on average with respect to measured and unmeasured characteristics. It does not guarantee that every characteristic is balanced in a study of this size, and it does not remove uncertainty from outcome comparisons. The record identifies the study as randomized but does not describe how the random sequence was generated or concealed. Baseline characteristics and a baseline-adjusted primary analysis are not reported in the registry record.

The registry lists the primary comparison as a superiority analysis. That label identifies the type of question, but does not by itself establish that the data demonstrate superiority. The reported p-value, estimated difference, and interval need to be interpreted together. The trial’s original analysis plan, including its significance threshold and any planned covariate adjustment, is not reported in the registry record. The 0.05 value listed for sample-size planning is a planning assumption, not a substitute for a missing description of the original analysis plan.

11. Confidence Intervals and Precision

The primary mean difference is 1.8, with an interval from -9.145 to 12.74. The difference is calculated as paper booklet minus mobile application. On the outcome’s direction, a positive value means a higher average score in the paper booklet group, while a negative value means a higher average score in the mobile application group. The interval includes zero and values on both sides of zero, so the data do not pin down the direction of the difference.

The interval also communicates that the estimate is not precise enough to restrict the plausible group difference to a narrow range. Its endpoints correspond to differences that may be important or unimportant, but the registry record does not specify a threshold for meaningful change. That absence prevents a direct assessment of whether the interval excludes effects that would matter to patients or researchers.

Confidence intervals are general statistical tools for describing uncertainty in an estimate. Their interpretation depends on the procedure and its assumptions. The confidence level for this interval is not reported in the registry record. It is therefore appropriate to discuss the reported bounds and their inclusion of zero, but not to attach an unreported confidence percentage.

The primary result should not be reduced to the p-value alone. The sponsor-reported p-value is 0.740, and the unadjusted recalculation is 0.747; neither conveys the full range of uncertainty. The means and standard deviations describe the observed groups, while the interval describes uncertainty in their contrast. Together, these statistics support a cautious reading: the point estimate is near zero on the scale, but the interval still permits a range of group differences in either direction.

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 illustrations are planning calculations based on the observed effect, not the trial’s own original design assumptions. The registry record does not report the original sample-size rationale or the assumptions used when the study was designed. The illustrations use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each row considers detecting a stated fraction of the observed effect: 100%, 75%, or 50%.

For these continuous outcomes, the figures are participants per arm, not a total across both arms and not total events. The 80% power column indicates the number of participants per arm that the planning calculation associates with an 80% chance of detecting the selected effect under those assumptions, if that effect is the true one. The 90% power column represents a higher chance under the same planning framework and therefore requires a larger planned group size. These are prospective planning quantities, not descriptions of what happened in the completed study.

As the selected effect becomes smaller, it is harder to distinguish it from random variation. The illustrations therefore require more participants per arm for the 75% and 50% fractions than for the full observed effect. This pattern is a general feature of power planning: smaller target differences usually call for more information, while higher desired power also generally calls for more information.

The curve should be read as a visual representation of how planned sample size changes across the effect assumptions used for the calculation, rather than as an additional outcome from the trial. These values are planning illustrations and are not observed power. They do not indicate the probability that the completed study’s result is correct, and they do not establish that the study was adequately or inadequately sized under its original protocol.

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 = 1.800; pooled standard deviation σ = 17.659.
2. n = 2 × (1.96 + 0.842)² × 17.659² / 1.800² = 1,510.8, rounded up to 1,511 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 <- 1.8                      # observed difference in means
sigma <- 17.6585673258053                     # 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(3004911)
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 = 1,511 (80% power), 2,023 (90% power)
 75% of observed effect: n per arm = 2,686 (80% power), 3,596 (90% power)
 50% of observed effect: n per arm = 6,044 (80% power), 8,091 (90% power)
power.t.test: 1511.7 
Simulated power at n = 1,511 per arm: 0.798 (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. Analyses Reported by the Sponsor

The sponsor-reported primary analysis is a two-sided t-test with p = 0.740. The simple unadjusted recalculation from the posted group summaries gives a mean difference of 1.8 and p = 0.747, with an interval from -9.145 to 12.74. The recalculation uses the posted means, standard deviations, and group sizes and is not an adjusted analysis.

The posted results also give group means of 53.7 for the mobile application and 55.5 for the paper booklet, with standard deviations of 17.1 and 18.2, respectively. The direction of the recalculated contrast is paper booklet minus mobile application. The interval includes zero and spans values in both directions, so the recalculation likewise does not identify a clear difference.

The two p-values are close but are not identical. A recalculation from summary statistics is a check of the unadjusted comparison, not a replacement for the sponsor’s analysis or its access to study-level data. The sponsor’s reported method and result should be distinguished from this simple recalculation. The registry record does not report whether the sponsor’s analysis included adjustments or other features beyond the stated two-sided t-test, so no such features should be assumed.

15. Multiplicity, Missing Data and Analysis Populations

The record identifies one primary outcome and several secondary outcomes. Testing multiple outcomes can increase the chance of finding an apparently unusual result even when there is no underlying difference. Statistical approaches can address this issue by controlling a family-wise error rate, adjusting p-values, or defining a hierarchy of tests. Whether any such approach was planned or used is not reported in the registry record. The posted secondary p-values should therefore be read as unadjusted results, not as multiplicity-controlled evidence.

Details about missing outcome data are also not reported in the registry record. The primary outcome summaries list 20 participants in each group, but the record does not explain whether these counts represent everyone assigned, everyone assessed at 6 weeks, or a particular analysis population. It does not report the amount or pattern of missing data, reasons for missingness, or any imputation or sensitivity analyses. The posted summaries alone cannot establish how missing observations, if any, were handled.

The analysis population is not described. In particular, the registry does not say whether the primary analysis followed an intention-to-treat approach, included only participants who completed the intervention, or used another definition. The available group sizes are outcome-summary counts, not a substitute for a clearly stated analysis-population rule.

The record reports a t-test for the primary comparison, but does not provide the full statistical analysis plan, the test’s assumptions as assessed in these data, a confidence level for the interval, or details of any covariate adjustments. The 0.05 significance level appears among the sample-size planning assumptions; it does not establish the decision threshold used in the trial’s original analysis. These reporting gaps limit assessment of multiplicity, missing-data bias, and whether the posted analysis followed a prespecified plan.

16. 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 5% reporting threshold.

For the mobile application group, the registry records 20 participants at risk for serious adverse events and 0 affected. For the paper booklet group, it likewise records 20 at risk and 0 affected. The other-adverse-event figures are also 20 at risk and 0 affected in each group. Deaths are recorded as 0 in each group.

These entries mean that the registry reports no events in the listed categories for the participants counted as at risk. They do not prove that no adverse experiences occurred outside the recorded categories or reporting period, and they cannot establish that either approach is free of risk. The registry record does not provide event definitions, the method of collection, or further detail about monitoring and follow-up for safety.

The safety counts should be interpreted alongside the outcome results, not as evidence about efficacy. With no recorded events in these categories, the registry does not provide a basis for estimating comparative event patterns beyond the posted counts. The short-term timeframe and the scale of this study also limit what these zero counts can establish about uncommon events.

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

The results describe a randomized comparison of a mobile application and a paper booklet for patients with fibromyalgia. At 6 weeks, the mobile application group had a mean health-related quality-of-life score of 53.7 and the booklet group had a mean of 55.5. Because higher scores are worse on this measure, the point estimate is numerically in the direction of a lower, better average score for the mobile application group. The estimated difference is uncertain, however, and its interval includes zero and values favoring either group.

The sponsor-reported p-value and the unadjusted recalculation do not establish a clear difference in the primary outcome. This is not the same as demonstrating equivalence or proving there is no effect. The interval allows a range of differences, and the record does not identify a threshold for a meaningful change. The posted findings therefore do not settle whether a possible difference would matter to patients.

The study summary describes a goal of promoting self-care and improving symptoms and health-related quality of life. The primary result addresses the health-related quality-of-life measure at the recorded follow-up, not every part of that broader aim. Numerical results for some secondary measures are posted, while results for the named self-care agency and application-use measures are not reported in the registry record.

These results do not establish that the application works or does not work. They also do not show that the application and booklet are interchangeable. The evidence is specific to the comparison, measure, participants, and 6-week timeframe recorded for this study. The registry’s missing details about the analysis population, missing data, and original design assumptions further constrain interpretation. Further evidence would be needed to assess other outcomes, timeframes, and populations.

18. Why This Trial Matters Statistically

This trial illustrates why a point estimate and a p-value are not enough to characterize a clinical comparison. The mean difference is 1.8, but its interval ranges from -9.145 to 12.74. The point estimate alone might make the groups appear close, while the interval shows that the data remain compatible with a broader range of possible contrasts. Precision is essential when interpreting a result that does not show a clear group separation.

It also illustrates the distinction between absence of clear evidence for a difference and evidence that groups are equivalent. A test result with a large p-value does not establish equivalence; that would require an appropriate design and a prespecified equivalence margin, neither of which is reported in the registry record. The direction of the score also matters: higher values mean worse outcome, and the comparison is expressed as paper booklet minus mobile application.

The posted sample-size illustrations reinforce how strongly planning depends on the target effect and desired power. Smaller effects call for larger planned groups under the listed assumptions. Those calculations do not describe the original trial design or the probability that its result is correct. Keeping planning illustrations separate from the completed study’s findings prevents a common misunderstanding of power calculations.

Finally, the registry record makes the limits of reporting visible. It identifies a randomized design and a primary measure, but does not report several details needed to fully assess the analysis, missing data, multiplicity, or sample-size rationale. Clear reporting of those elements is part of making clinical evidence interpretable, not merely a technical formality.

19. 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 enrollment was 40, and the primary outcome summaries list 20 participants in each group. The confidence interval for the primary difference is broad enough to include values in either direction, limiting precision. The study’s results therefore do not tightly determine the size or direction of a possible group difference.

The primary outcome was assessed at 6 weeks. The registry record does not provide a longer-term result, so the posted comparison cannot describe whether the groups’ outcomes persisted or changed later. The record also does not provide a threshold for a clinically meaningful difference, making it difficult to interpret the interval in terms of importance to patients.

The study summary refers to Brazilian patients with fibromyalgia, and generalization beyond that described population should be cautious. The registry lists a single masking status but does not identify who was masked. It also does not describe the allocation sequence, intervention use, adherence beyond naming an app-click measure, or other care received by participants. These omissions limit assessment of how the comparison was implemented.

Several analysis details are not reported in the registry record, including the original sample-size rationale, the analysis population, handling of missing data, baseline outcome values, and multiplicity procedures. The record lists five secondary outcomes, but numerical results are posted for only three. These reporting limitations do not negate the posted results, but they restrict the conclusions that can be drawn from them.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia — NCT03004911.
• Registry record last updated 2019-06-17; status last verified 2016-12.
• Results first posted 2019-06-17.
• 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.

23. Record Summary

The registry record describes a completed randomized, single-masked, parallel-group study sponsored by University of Sao Paulo General Hospital. It lists enrollment of 40 and compares the ProFibro mobile application with a paper booklet in patients with fibromyalgia. The primary endpoint is health-related quality of life assessed with the Revised Fibromyalgia Impact Questionnaire at 6 weeks.

The primary group means were 53.7 for the mobile application and 55.5 for the paper booklet, with a reported mean difference of 1.8 and an interval from -9.145 to 12.74. The sponsor-reported two-sided t-test gave p = 0.740; an unadjusted recalculation gave p = 0.747. The interval includes zero and both directions of difference.

Numerical results are posted for three secondary outcomes. Results for the remaining named secondary outcomes, and several details of the original design and analysis plan, are not reported in the registry record. The findings are a short-term comparison and do not establish equivalence or settle the broader claims in the study summary.