Online Education and Gentle Exercise Intervention: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Online Education and Gentle Exercise Intervention (NCT03440320), a randomized na study. The primary outcome is Brief Pain Inventory.

2. Clinical Question

3. Trial Design

The registry lists NCT03440320 as a completed, randomized, double-masked, parallel-group study sponsored by Colorado State University. Its phase is listed as NA. The registered enrollment is 32. The record gives a start date of 2018-03-29 and a primary completion date of 2021-05-12.

The two online behavioral interventions are MY-Skills and MY-Plan control. Each arm description specifies an 8-week class with 16 sessions. Both descriptions include approximately an hour of light exercise and an hour of education per class, designed for a caregiving dyad with chronic pain. These descriptions do not identify how the education content differed between arms or who was masked; those details are not reported in the registry record.

The study summary describes an aim to develop and standardize the Education and Gentle Exercise intervention and a control intervention, as well as to assess feasibility and acceptability. It describes a planned allocation of 15 dyads to each group, or 30 dyads/60 participants. The registry’s enrollment figure is 32; the record does not explain how that enrollment relates to the planned dyad and participant counts.

The posted outcome data distinguish caregivers from care receivers within each assigned intervention. The record reports Brief Pain Inventory change summaries for each of those four groups. It does not report an inferential analysis comparing the randomized arms. Randomization is part of the registered design, but the absence of a reported comparison means the posted summaries alone do not quantify an intervention effect.

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 Brief Pain Inventory, measured over Administered at baseline and again following the 8-week intervention.

The primary endpoint is change from baseline in Brief Pain Inventory score following the 8-week intervention. The measure’s scores range from 0 to 10, with higher scores indicating more severe pain and greater interference. The reported change score has a possible range from -10 to 10. Negative changes indicate a decrease in pain severity and interference; positive changes indicate an increase.

Caregivers and care receivers completed the assessment on their own pain. Reporting them separately preserves that distinction: the summaries describe the pain scores of two different participant roles rather than a single combined dyad score. The registry reports a mean and standard deviation for each role within each arm.

In general, a change-from-baseline endpoint expresses how an outcome differs from its starting measurement. It can describe the direction and spread of observed changes, but a mean change within an arm is not itself a randomized comparison. To estimate the difference attributable to assigned groups, an analysis must compare the arms using a specified statistical approach. Such an analysis is not reported in the registry record.

The registry summary emphasizes feasibility and acceptability as study aims, including recruitment, screening, attendance, and completion. The posted primary outcome, however, is pain change on the Brief Pain Inventory. The registry record does not provide a reported result for the feasibility benchmarks in the summary.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What do the posted summaries describe?

The primary outcome is continuous: it is a numerical change score on the Brief Pain Inventory. The registry reports a mean change and a standard deviation for caregivers and care receivers in each intervention group. A mean describes the central value of the observations in a group. A standard deviation describes how dispersed individual observations are around that group’s mean. In general, neither summary alone describes uncertainty in a comparison between groups.

The outcome’s direction is defined in the registry. Negative change scores indicate decreases in pain severity and interference, while positive scores indicate increases. The four group summaries therefore describe observed direction and variability separately for caregivers and care receivers. They do not provide an adjusted or unadjusted between-arm estimate, and the registry record does not report an inferential test for the primary outcome.

Why does a randomized comparison matter?

In general, random assignment is intended to make treatment groups comparable on average, including with respect to factors that may affect outcomes. An analysis that compares the assigned groups can use that design to estimate a contrast between their outcomes. A mean within one group, considered alone, does not answer the comparative question. Nor does comparing two displayed means by eye provide a confidence interval or a test of statistical evidence.

For this study, the registry record lists the design as randomized and parallel, but reports no analysis for the continuous primary endpoint. It states that values are missing or not estimable for a two-arm comparison. The statistical model, covariate adjustment, handling of the caregiving-dyad relationship, and method for calculating uncertainty are not reported in the registry record. No comparison should be reconstructed from the descriptive summaries as though it were the sponsor’s analysis.

What would a confidence interval communicate?

In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of the statistical method. Its width reflects precision: wider intervals indicate greater uncertainty, while narrower intervals indicate greater precision. A confidence interval around a between-arm estimate would help readers assess both the plausible size and direction of the contrast. No such interval is reported in the registry record for the primary outcome.

A p-value, in general, describes how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the model assumptions held. It is not the probability that a treatment works, nor does it describe the magnitude or clinical importance of an effect. No p-value for the primary comparison is reported in the registry record.

How should the standard deviations be read?

The reported standard deviations characterize variation among the observed change scores in each group. They are not standard errors and are not confidence limits. In general, the standard error of a mean or group contrast reflects precision and depends on the amount of information as well as the observed variability. The registry record does not report standard errors or confidence intervals for these summaries.

In general, over-dispersion means that observed variability is greater than a statistical model expects. When a model assumes less variability than the data contain, its uncertainty estimates may be too small and its tests may be misleading. Whether over-dispersion is relevant to an analysis of this endpoint cannot be assessed from the posted means and standard deviations alone. The registry record does not report a model or a diagnostic assessment for over-dispersion.

What does the planning illustration represent?

In general, a sample-size calculation asks how many participants would be needed to detect a specified effect with chosen assumptions about statistical significance, allocation, and the data model. The registry record’s planning description specifies a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect framed as a stated fraction of the observed effect. Such planning illustrations are not the trial’s observed results, and they are not observed power.

The record does not report a protocol-based sample-size justification. The stated planning illustration is explicitly not the trial’s own design. Because a between-arm effect for the continuous endpoint is not reported as estimable, the posted record does not establish a sponsor-reported effect on which to base a comparative interpretation. The planning assumptions should therefore be understood as illustrative rather than as evidence that the trial was designed to detect a particular clinically meaningful difference.

What can the displayed group counts tell readers?

The participant counts attached to the means are 9 caregivers and 8 care receivers in MY-Skills, and 6 caregivers and 7 care receivers in MY-Plan control. In general, smaller groups yield less precise estimates, particularly when individual observations vary. The reported standard deviations show that the observed change scores were not identical within groups, but they cannot by themselves establish how precise a between-group contrast would be. The registry record does not explain why the endpoint group counts differ or how missing outcome assessments were handled.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Online Pilot, MY-Skills (Intervention), Caregivers", "Online Pilot, MY-Skills (Intervention), Care Recei", "Online Pilot, MY-PLAN (Control), Caregivers", "Online Pilot, MY-PLAN (Control), Care Receivers")
n   <- c(9, 8, 6, 7)
m   <- c(0.23, -0.29, -1.38, -1.32)
sp  <- c(1.34, 1.63, 1.83, 1.87)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Online Pilot, MY-Skills (Intervention), Caregivers  9  0.230  1.340  -0.800  1.260
CARM  Online Pilot, MY-Skills (Intervention), Care Recei  8  -0.290  1.630  -1.653  1.073
CARM  Online Pilot, MY-PLAN (Control), Caregivers  6  -1.380  1.830  -3.300  0.540
CARM  Online Pilot, MY-PLAN (Control), Care Receivers  7  -1.320  1.870  -3.049  0.409

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure and zero posted analyses. It identifies the Brief Pain Inventory change as the primary outcome, but does not report a statistical analysis plan, a testing hierarchy, or a procedure for controlling multiplicity. It is therefore not possible to determine from the record whether other planned outcomes or subgroup analyses were intended, or how any multiple comparisons would have been addressed.

In general, multiplicity arises when several statistical hypotheses are tested; repeated testing can increase the chance of a false-positive finding unless the analysis accounts for it. This general concern does not establish that multiple tests were conducted in this study. The registry record does not report such tests.

The posted arm summaries include caregivers and care receivers separately. The record does not state whether these roles were prespecified as separate primary analyses, whether one was intended as the principal population, or whether results were meant to be combined. The analysis population and handling of the dyadic relationship are not reported in the registry record.

Missing-data methods are also not reported in the registry record. The record does not provide a participant flow, counts assessed at each time point, reasons for missing assessments, or a description of imputation or other missing-data procedures. The different counts attached to the four outcome summaries cannot, on their own, identify why observations are absent or how missingness may affect interpretation.

The summary describes feasibility benchmarks, including recruitment, screening, attendance, and completion of assessments and intervention. Numerical results for those benchmarks are not reported in the registry record. Without an analysis plan and those supporting details, readers cannot determine how feasibility was defined, whether benchmarks were met, or which participants were included in each analysis.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: extreme leg pain (7.1%), high blood pressure (5.6%).

The registry lists serious adverse events for 18 participants at risk in the MY-Skills intervention group and 14 at risk in the MY-Plan control group. One participant in each group is listed as affected by a serious adverse event. No deaths are listed in either group. The registry lists zero other adverse events in both groups.

The serious-event terms listed are Extreme leg pain, 7.1%, and High blood pressure, 5.6%. The registry record does not identify which group each term belongs to or provide further event-level details. It does not report whether events were judged related to an intervention, their timing, severity beyond the serious-event classification, or how many events each affected participant experienced.

In general, adverse-event counts describe events recorded during a study; they do not by themselves establish that an intervention caused an event. A comparison of safety between groups also requires attention to the amount of follow-up and the populations observed. Those details are not reported in the registry record. The small listed group counts and limited event information mean these figures should be read descriptively, not as a definitive estimate of comparative safety.

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

The posted results describe average change in Brief Pain Inventory scores within four participant groups: caregivers and care receivers assigned to MY-Skills or MY-Plan control. They also show the observed spread of scores through group standard deviations. Under the registry’s scoring description, negative values indicate decreases in pain severity and interference and positive values indicate increases.

Those summaries do not establish whether one assigned intervention produced a different change from the other. The registry record reports no between-arm estimate, confidence interval, or p-value for the primary endpoint, and it indicates that a two-arm comparison was not estimable from the posted values. The numerical pattern in group means should not be treated as a formal comparison or a causal estimate.

The record describes a pilot focused on developing the intervention and assessing feasibility and acceptability. It does not report numerical outcomes for its stated feasibility benchmarks, so those aims cannot be evaluated from the registry record. The record also does not report a protocol-based sample-size justification or a statistical analysis plan.

The findings do not show how representative the participants were of other people with chronic pain or caregiving dyads, and the record does not report enough information to assess that question. They also do not establish whether observed changes were clinically important, because no threshold for clinical importance is reported. The event listings similarly do not establish causation or a comparative safety difference.

In general, pilot findings can describe how an intervention was tested and identify questions for more complete evaluation. They are not a substitute for a reported comparative analysis. The most defensible reading is limited to the descriptive outcome summaries, the registered study design, and the safety counts recorded for this study.

14. Why This Trial Matters Statistically

This trial illustrates an important distinction between a study’s stated purpose and the outcome for which numerical results are posted. The registry summary describes intervention development and a feasibility-and-acceptability aim, while the posted primary outcome is change in Brief Pain Inventory score. Those are related parts of the study record, but answering one does not automatically answer the other.

It also shows why role-specific reporting matters in dyadic research. Caregivers and care receivers completed assessments on their own pain, and their results are listed separately. A single combined summary could obscure differences between participant roles. At the same time, the registry record does not explain whether or how the statistical analysis accounted for the relationship within each caregiving dyad.

Randomization makes a direct comparison of assigned groups a natural statistical question. Yet descriptive means and standard deviations are not enough to show the precision of that comparison. The absence of a reported between-arm estimate, uncertainty interval, and analysis method limits what readers can conclude from the posted pain results.

The enrollment figure and the planned dyad and participant counts in the study summary are also distinct pieces of information. The record does not reconcile them, underscoring why participant flow and clear analysis populations are important for interpreting trial outcomes.

These features make the record useful for statistical reading: it distinguishes design labels, descriptive outcomes, and missing inferential results. The study can be described as a randomized online pilot with posted role-specific pain summaries, while the comparative effect and feasibility outcomes remain unreported in the registry record.

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 registry record does not report an inferential analysis of the primary endpoint. It provides group means, standard deviations, and participant counts, but no between-arm estimate, confidence interval, or p-value. The record also indicates that values are missing or not estimable for a two-arm comparison. This leaves the comparative question unanswered by the posted outcome data.

Although the record identifies a randomized, double-masked, parallel design, it does not describe the sequence generation, allocation concealment, who was masked, or whether masking was maintained. Details of the statistical model, covariate adjustment, and treatment of the dyadic relationship are also not reported in the registry record.

The registered enrollment is 32, whereas the study summary describes a planned 30 dyads/60 participants. The record does not explain this difference or give a participant-flow account. It does not report reasons for missing assessments, missing-data methods, or the analysis population. The counts attached to the endpoint summaries are small and differ by participant role and group, limiting the information available for interpreting precision.

The registry describes feasibility and acceptability benchmarks, but numerical results for recruitment, screening, attendance, and completion are not reported. The record does not provide a protocol-based sample-size justification, a threshold for clinically important change, or enough detail to interpret the listed serious-event terms by group or relationship to intervention.

Finally, the intervention and control descriptions both include exercise and education, while the registry record does not specify how their educational content differed. The reported arm-level changes should therefore be understood within the stated descriptions and not as evidence about a particular intervention component.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Online Education and Gentle Exercise Intervention — NCT03440320.
• Registry record last updated 2025-06-13; status last verified 2025-06.
• Results first posted 2021-07-09.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT03440320 is listed as a completed randomized, double-masked, parallel-group online behavioral study sponsored by Colorado State University. The record gives a registered enrollment of 32, a start date of 2018-03-29, and a primary completion date of 2021-05-12. Its study summary describes intervention development and a pilot assessment of feasibility and acceptability for caregiving dyads affected by chronic pain.

The primary posted outcome is change from baseline in Brief Pain Inventory score after the 8-week intervention. Mean changes and standard deviations are listed separately for caregivers and care receivers in MY-Skills and MY-Plan control. The registry record reports no statistical analysis comparing the groups and no numerical results for the stated feasibility benchmarks. Serious adverse-event counts are listed for both groups, with no deaths reported.

Interpretation is consequently limited to the descriptive outcome and event summaries. The record does not report the analysis methods, missing-data procedures, or a reconciliation of registered enrollment with the planned dyad and participant counts described in its summary.