The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain (NCT05387447), a randomized na study. The primary outcome is Self-reported Pain Severity.

2. Clinical Question

This is a comparison of two versions of a technology-based interaction, not a comparison between receiving a voice assistant and receiving no intervention. Random allocation supports a comparative design, but the registry record does not describe how allocation was generated or concealed. The record also does not report whether the primary analysis compares change from baseline, scores at 12 weeks, or another contrast. Those choices affect the interpretation of an estimated treatment difference, so the absence of a posted estimate and analysis details limits what can be concluded from the registration information alone.

3. Trial Design

The registry describes a randomized, parallel-group behavioral trial comparing Conversational Voice Assistant (Enhanced) with Conversational Voice Assistant (Standard). The enhanced arm is described as a personalized and tailored interactive routine; the standard arm uses a standard interactive routine. The record lists no masking. It reports a planned enrollment of 58 and a completed status, with the study start and primary completion dates recorded as 2022-03-01 and 2023-12-30.

The sponsor is the University of Nebraska. The registry lists the phase as NA. It names chronic pain and loneliness as conditions and identifies self-reported pain severity as the primary outcome, measured at baseline and 12 weeks. Secondary outcomes are conversational voice assistant system usability, geriatric depression, and self-efficacy for managing symptoms. The record lists five outcome measures overall, but does not describe the additional measures in the registry record for this account.

Enrollment is a registry planning figure; it should not be treated as the number analyzed or as evidence that every enrolled participant completed follow-up. The registry record does not report the number randomized to each arm for the primary outcome, the numbers with observed measurements, or participant flow through the study. Although adverse-event entries list 25 people at risk in each arm, those entries do not establish the analysis population for pain outcomes.

Further operational details are not reported in the registry record. These include allocation generation and concealment, the setting and duration of participation, intervention fidelity, adherence, and any co-interventions. Without those details and the outcome estimates, the registered design can be described, but its implementation and the magnitude or precision of the comparative pain result cannot be assessed.

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 Self-reported Pain Severity, measured over Baseline and 12 weeks.

The primary endpoint is self-reported pain severity measured with the Brief Pain Inventory Short Form. The registry describes a score from 0, meaning minimal score with no pain or pain interference, to 10, meaning maximum score corresponding to severe pain or complete pain interference. Higher scores indicate worse symptoms. The assessment time points are baseline and 12 weeks.

A patient-reported score can capture the participant's experience of pain and interference rather than relying only on an external assessment. Repeated measurement can also describe pain at the start of the study and later follow-up. As a general statistical point, the interpretation of change depends on how measurements are compared: a difference in follow-up scores, a difference in change from baseline, and an adjusted estimate are not interchangeable in every setting. The registry record does not specify which contrast was used.

The record does not report the primary outcome means, standard deviations, between-arm estimate, confidence interval, or test result. It also does not state whether the measure was analyzed as a continuous score at each time point or through a change score or other model. Therefore, the outcome definition is clear enough to describe the direction of the scale, but it is not possible to assess the observed pain result or its precision from the registry information alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes random allocation to two parallel groups. In general, randomization is intended to make treatment assignment independent of participant characteristics at the time of assignment. It can support a causal comparison when the trial is conducted and analyzed appropriately, but randomization by itself does not guarantee balanced groups in a particular trial or resolve problems from missing outcomes, non-adherence, or selective reporting. The registry record does not describe the sequence-generation or concealment procedures, so those aspects cannot be evaluated.

What does a mean and standard deviation describe?

The primary measure is a continuous pain score, and the registry identifies the mean as the summary parameter and standard deviation as the dispersion measure. In general, a mean describes the central level of a set of scores. A standard deviation describes how spread out individual scores are around that mean. The standard deviation is not the uncertainty of the mean; uncertainty in an estimated group mean or group contrast is usually expressed through a standard error or confidence interval.

The registry record does not give group means or standard deviations for the pain outcome. These registered summary choices therefore describe the planned form of reporting, not observed values that can be interpreted. The scale runs from 0 to 10, and higher values indicate worse symptoms. Because the score is bounded, its distribution and any departures from model assumptions can matter. Whether distributional checks or alternative analyses were used is not reported in the registry record.

What would a between-group estimate mean?

A comparative estimate would summarize how the outcome differed between the enhanced and standard routines under a specified analysis. In general, an estimate is more informative when accompanied by a confidence interval and a clear definition of the contrast. A p-value alone would not communicate the size of the difference or its precision. The registry does not report a between-group estimate, confidence interval, or p-value for the primary outcome.

The record identifies baseline and 12-week measurement, but does not state whether the analysis used follow-up scores, change from baseline, or a repeated-measures model. These methods can answer related but distinct questions. Adjustment for baseline values may improve precision in some settings, but no such adjustment should be assumed. The statistical model, covariates, and handling of repeated measurements are not reported in the registry record.

How should planning calculations be read?

The record describes planning illustrations based on a fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation. In general, a sample-size illustration asks what study size would be needed under stated assumptions to detect a target effect with a chosen power. It is a planning exercise, not evidence that the trial had that power and not a measure of the probability that the result is true.

The planning description does not make the illustrated size the trial's original design justification. The registry record does not report a protocol-based sample-size calculation or the assumptions used in the original design. Nor does it report a numerical observed primary effect in the information available for interpretation. Without that result and the specific illustration outputs, no particular planning size or detectable effect can be assessed.

What cannot be inferred from the analysis record?

The registry lists four analyses and five outcome measures, but those counts do not disclose the statistical procedures or the results. The record does not identify a primary analysis population, describe an intention-to-treat approach, or report per-protocol or safety analysis definitions. It does not say how missing values, protocol deviations, or non-adherence were handled. These details influence what population an estimate represents and how robust it may be.

General statistical interpretation also depends on the distinction between uncertainty and importance. A confidence interval that excludes a null value, if one were reported, would address compatibility with a statistical null under the model; it would not by itself establish clinical importance. Conversely, an imprecise result would not establish equivalence. No clinical threshold for meaningful change is reported, and no outcome estimate is available for judging either issue.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures and four analyses. It names self-reported pain severity as the primary outcome and lists conversational voice assistant system usability, geriatric depression, and self-efficacy for managing symptoms as secondary outcomes. The record does not describe how the additional outcome measures relate to those listed outcomes or which analyses correspond to each measure.

When several outcomes, time points, or comparisons are examined, the chance of at least one apparently unusual result can increase. As a general statistical principle, a prespecified hierarchy or multiplicity adjustment can help control interpretation across multiple tests. The registry record does not report a testing hierarchy, adjustment method, or plan for selecting among time points. The primary outcome itself is noted as having several categories or time points and is not reduced to one comparison in the record available for interpretation.

Missing-data handling is also not reported in the registry record. It does not state how many participants had pain assessments at baseline or 12 weeks, how missing observations were handled, or whether sensitivity analyses were performed. General approaches can include model-based methods or imputation, but no particular approach should be attributed to this trial.

The record does not define the primary analysis population or report whether analyses followed randomized assignment. It also does not describe exclusions, protocol deviations, or rules for including participants with incomplete follow-up. Without these details, it is not possible to assess the completeness of the primary outcome analysis or the potential influence of missing data and analysis choices.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry's adverse-event entries list the standard and enhanced voice assistant arms separately. For each arm, 25 people are listed as at risk; serious events, other events, and deaths are each recorded as 0. These are the figures entered in the registry record, not a full description of how safety was monitored.

A count of 0 means that no events of the listed type are recorded in these entries. It does not establish that the intervention has no risk, and it does not show whether every participant was monitored for the same length of time or with the same completeness. The record does not report event definitions, collection procedures, observation periods, or whether event reporting was limited to events judged related to the intervention.

The at-risk counts in the safety entries should not be treated as the denominators for the pain outcome analysis. The registry does not report the number of participants contributing primary outcome data or explain how these safety counts relate to the enrollment figure. The safety entries therefore describe the recorded counts, but do not support broader conclusions about comparative safety.

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

The record establishes that the trial was designed as a randomized, parallel-group comparison of a tailored enhanced conversational voice assistant routine with a standard routine. It identifies chronic pain and loneliness as conditions of interest and specifies self-reported pain severity as the primary outcome, assessed at baseline and 12 weeks. It also names secondary outcomes concerning system usability, geriatric depression, and self-efficacy for managing symptoms.

The registry information does not include numerical results for the primary pain outcome. It therefore does not establish whether scores differed between the groups, how large any difference was, or how precisely it was estimated. The absence of a reported estimate is not evidence that the groups were the same, just as it is not evidence that they differed. It means the comparative outcome cannot be evaluated from this record alone.

Even when a result is available, statistical significance and clinical importance are different questions. A test result concerns compatibility with a statistical model and a null hypothesis; clinical importance concerns whether a difference matters in context. The registry record does not specify a threshold for a meaningful pain change, and it does not report a comparative estimate to assess against such a threshold.

The intervention descriptions also do not allow the effect of the voice assistant as a whole to be separated from the effect of tailoring. Both groups receive an interactive voice assistant routine, and the registered contrast is enhanced versus standard. Details about routine content, adherence, and additional care are not reported in the registry record.

The results should not be extended beyond the population and setting actually studied. Detailed eligibility criteria, participant characteristics, and the analyzed population are not reported in the information. The registry entry is useful for identifying the study question and registered outcome, but a conclusion about the observed comparative effect requires outcome estimates, uncertainty intervals, analysis methods, and participant-flow information.

13. Why This Trial Matters Statistically

This trial raises a statistical question that is more specific than whether a technology-based interaction is associated with an outcome. The registered comparison is between a personalized and tailored routine and a standard routine, both delivered through a conversational voice assistant. That distinction matters because the estimate, if reported, would address the contrast between two routine formats rather than the effect of using an assistant versus not using one.

The primary measure is a continuous self-reported pain score recorded at baseline and 12 weeks. Repeated measurements make the definition of the comparison important: a follow-up contrast and a change-from-baseline contrast answer related but not identical questions. Clear reporting of the estimate, interval, time point, and model would allow readers to understand what was compared and how uncertain the result is. Those details are not reported in the registry record.

The study also illustrates why outcome multiplicity and missing-data reporting matter. The registry lists several outcome measures and notes multiple categories or time points for the primary outcome, but does not describe a testing hierarchy or missing-data strategy. Without that information, readers cannot assess how outcome selection and incomplete follow-up may shape the interpretation.

Finally, a completed trial status and a registered enrollment figure are not substitutes for results. Statistical assessment needs the analyzed data, the estimate, its precision, and enough methods detail to judge the assumptions. The record establishes a question of interest and a comparison, but does not supply the numerical primary result needed to answer that question.

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 limitations of interpretation follow from what is not reported in the registry record. Detailed eligibility criteria and participant characteristics are absent, limiting assessment of who entered the study and to whom the findings might apply. The planned enrollment is recorded, but the number randomized by arm and the number analyzed for the primary outcome are not reported in the information.

The primary outcome is described at baseline and 12 weeks, but a single primary contrast is not identified. The record does not report outcome values, an effect estimate, a confidence interval, or a test result. It also does not specify whether the comparison used follow-up scores, change from baseline, or a repeated-measures approach. These omissions prevent assessment of the result's direction, size, and precision.

The record does not report allocation-concealment procedures, intervention adherence, fidelity, or the degree of separation between the tailored and standard routines. Masking is listed as none. The implications of that design feature for participant-reported outcomes cannot be quantified from the registry alone.

Outcome hierarchy, multiplicity procedures, missing-data methods, and analysis-population definitions are not reported. The record also does not provide a protocol-based sample-size justification or enough primary outcome information to interpret planning illustrations. Safety entries list counts, but do not describe event definitions, surveillance, or observation duration. These reporting gaps do not prove that the methods were inadequate; they limit what can be checked from the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain — NCT05387447.
• Registry record last updated 2025-05-23; status last verified 2025-05.
• Results first posted 2025-05-23.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry describes a completed randomized, parallel-group trial sponsored by the University of Nebraska. It compares a personalized and tailored conversational voice assistant routine with a standard interactive routine. Masking is listed as none, the phase as NA, and planned enrollment as 58.

The primary outcome is self-reported pain severity on the Brief Pain Inventory Short Form, measured at baseline and 12 weeks. Higher scores indicate worse symptoms. Secondary outcomes include system usability, geriatric depression, and self-efficacy for managing symptoms.

The registry record does not report a numerical primary outcome result, the analysis method, the primary analysis population, or missing-data handling. Safety entries list 25 at risk in each arm and zero serious events, other events, and deaths in both arms. The outcome comparison's magnitude and precision cannot be assessed from the registry information alone.