A Trial of Telemonitoring in Adults With Heart Failure: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Trial of Telemonitoring in Adults With Heart Failure (NCT01393314), a randomized na study. The primary outcome is The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED)..

2. Clinical Question

The clinical question is about time to the first occurrence of either of two kinds of acute-care use, rather than the number of separate visits or readmissions. Combining these events can capture more than one route by which participants return for unplanned care, but it also means the endpoint does not distinguish which component accounts for a participant's event. The registry's description says the endpoint was intended to assess whether or when participants needed readmission or an emergency-department visit.

The study enrolled 99 participants and randomized them to the telemonitoring or usual-care group. The available primary results give group medians, but they do not provide the event counts, a hazard ratio, a confidence interval for a group comparison, or a reported statistical test. Accordingly, the medians describe the posted group summaries; they do not, on their own, resolve the comparative question.

3. Trial Design

The registry describes a randomized, parallel-group controlled trial without masking. One group received the Honeywell HomMed Telemonitor, and the other received usual home care with an educational package. The study is listed as completed, with enrollment of 99. The record identifies Case Western Reserve University as the sponsor and lists the study phase as not applicable.

Random allocation is intended to make the groups comparable on average at the start of a trial, including with respect to factors that may influence the outcome. It does not guarantee that the realized groups are identical, particularly in a trial of this size. The record does not report the randomization sequence method, whether allocation was concealed, or whether any stratification was used. Masking is listed as none; the record does not specify which study roles, if any, were unmasked beyond that classification.

The intervention was a device-based home monitoring system, while the comparator involved usual home care and education. The trial therefore compared care packages, not a device in isolation from all other care. The registry does not report the monitoring schedule, the actions taken in response to readings, or how consistently participants used the monitor. Those details are not reported in the registry record.

The primary endpoint was median time to a combined hospital-readmission or emergency-department event. The stated timeframe says participants were followed for the duration of home-care services, up to 12 months. The brief summary describes a hypothesis concerning several types of health-service use over the 60 day post-hospitalization period. How these descriptions map to the analysis window is not reported in the registry record.

The secondary outcome listed is the Kansas City Cardiomyopathy Questionaire. The registry gives group means and standard deviations for that outcome, as well as an unadjusted comparison calculated from the posted summaries. The protocol, sample-size justification, detailed statistical analysis plan, and rules for handling follow-up ending before an event are not reported in the registry record. Enrollment should therefore be understood as the recorded trial size, not as evidence that the study was designed with a particular power for the primary endpoint.

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 The Amount of Time Participants Are Readmitted to the Hospital or Visit the Emergency Department (ED)., measured over Participants were followed for the duration of home care services up to 12 months.

The primary endpoint is the amount of time until a participant is readmitted to the hospital or visits the emergency department. It is a time-to-event measure: the outcome combines whether an event occurs with when it occurs. The registry reports the median time for each group and describes follow-up as continuing for the duration of home-care services, up to 12 months.

A combined endpoint can represent a broader measure of acute-care use than either component alone. It may also be more informative than simply recording whether a participant ever had an event, because timing is retained. However, the combined measure cannot show whether any group pattern is driven mainly by readmissions, emergency-department visits, or both. Separate component results are not reported in the registry record.

The registry lists the endpoint dispersion as a standard deviation, while the central value is a median. These are different summaries: the median is the middle of an ordered set of observed times, whereas the standard deviation describes spread around a mean. The record does not explain this pairing or provide a confidence interval for either median.

For a time-to-event comparison, a group-level median is not a substitute for an analysis of the event-time distributions. The record does not report the number of participants experiencing the combined event, a hazard ratio, or a sponsor-reported test comparing groups. The reported medians therefore describe the endpoint in each arm, but do not establish the strength or precision of a comparative effect.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods answer different questions, and the distinction matters for interpreting this record. The primary outcome is a time-to-event endpoint, while the posted secondary outcome is summarized as a mean and standard deviation. Each type of outcome calls for summaries and comparisons that reflect its structure.

What does randomization contribute?

Randomization assigns participants to groups by chance. Its purpose is to reduce systematic differences in prognostic characteristics at the point of assignment, so that a well-conducted comparison can be interpreted as a comparison of assigned strategies rather than a comparison chosen by participants or clinicians. Randomization does not remove chance imbalance, guarantee adherence, or correct problems caused by missing outcome data. The record gives the randomized design and group sizes, but the sequence-generation and allocation-concealment methods are not reported in the registry record.

Masking is listed as none. In general, masking can reduce some forms of expectation or assessment bias, depending on who is masked and how outcomes are measured. For a device-based care intervention, masking participants or care teams may be difficult, but that practical consideration is general and the record does not state what procedures were feasible or attempted. It also does not identify a blinded outcome assessor.

How should a median time be read?

A median is a measure of the center of a distribution. For event times, it describes when the midpoint of the event-time distribution is reached under the analysis definition. Unlike a mean, the median is less influenced by very long or short values. But a pair of medians does not communicate the whole pattern of event timing, and it does not show how many participants remained under observation without an event.

Time-to-event analyses commonly need to account for censoring. Censoring occurs when a participant's event time is not observed through the end of their available follow-up, for example because observation ends before an event is recorded. General methods for these data can use the information available up to the last observation rather than treating a censored participant as though an event occurred at that time. The registry record does not report the censoring rules or the sponsor's method for this endpoint, so no particular method should be assumed.

The record's primary endpoint summary lists medians and standard deviations, but does not post a comparative hazard ratio, confidence interval, event count, or sponsor-reported test. A hazard ratio, when reported, compares event rates over follow-up under a model; it is not the same quantity as a difference between medians. The registry's note about using only sponsor-reported hazard ratios for time-to-event results does not supply one for this trial. Consequently, a comparative time-to-event estimate cannot be reconstructed from the posted medians alone.

What does the secondary mean comparison show?

The secondary score is summarized with a mean and standard deviation in each arm. A mean is the arithmetic center of the observed scores. The standard deviation describes how dispersed individual scores are around that mean. These summaries do not reveal the full score distributions, and their interpretation depends on which observations were included and how missing scores were handled. Those details are not reported in the registry record.

The unadjusted recalculation estimates the difference between the posted group means and uses the posted group standard deviations and sample sizes. It is called unadjusted because it does not control for baseline values or other covariates. A confidence interval expresses the range of values reasonably compatible with the data under the calculation's assumptions; it is not a guarantee that the true value lies within that particular interval. Here the recalculated interval includes zero, and the unadjusted p-value is 0.05. Because the registry lists no reported analysis for this endpoint, the calculation should be distinguished from a sponsor's prespecified model or conclusion.

General statistical interpretation also depends on assumptions such as independent observations and an appropriate model for the outcome. The planning illustration states a normal approximation and equal allocation. Those are assumptions for that illustration, not proof that the original trial used the same approach. The registry record does not report a detailed analysis plan for the secondary score.

How should planning quantities be interpreted?

Sample-size planning asks how many participants would be needed under specified assumptions to have a target probability of detecting an effect of a chosen size at a chosen significance level. The posted illustration uses a two-sided significance level of 0.05, equal allocation, and a normal approximation, and varies the effect to detect as a fraction of the observed secondary effect. The listed outputs are participants per arm for 80% or 90% power.

These figures are planning illustrations, not observed power and not a retrospective assessment that the trial succeeded or failed statistically. They depend on the assumed effect size; smaller target effects require larger planning samples under the illustration. Since the observed effect can be unstable, especially in a small study, planning around it does not guarantee that a future study will have the assumed effect. The original trial's own sample-size assumptions and justification are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists one secondary outcome and no reported analyses for it. It does not describe a prespecified hierarchy of outcomes, an adjustment for multiple testing, or how many analyses were considered. Without that information, the unadjusted secondary p-value cannot be interpreted as though it necessarily came from a single, fully prespecified test. If multiple outcomes or analytic choices were explored, the chance of at least one apparently notable result can be greater than the error rate for a single test. That is a general statistical issue; whether it affected this study cannot be determined from the record.

Missing-data handling is also not reported. The record provides group sample sizes for the outcomes but does not state whether every randomized participant contributed to each result, how incomplete questionnaires were handled, or what happened when follow-up ended before an acute-care event. For a time-to-event endpoint, the method for handling participants without an observed event is important. For the questionnaire, the approach to incomplete or unavailable scores can affect the analyzed group summaries. No imputation, censoring, or sensitivity-analysis method should be assumed.

The analysis populations are not described. The record does not state whether the analyses followed an intention-to-treat principle, included only participants who began the intervention, or used another population definition. Nor does it report exclusions after randomization or protocol deviations. These details matter because a comparison based on fewer than all randomized participants may lose some protection offered by randomization.

The record lists zero reported analyses for the primary endpoint and no sponsor-reported secondary analyses. This does not mean no analyses were conducted; it means their methods and results are not reported in the registry record. Consequently, the available evidence supports descriptive reading of the posted summaries and cautious reading of the recalculated secondary comparison, rather than reconstruction of the full analysis plan.

11. Safety Results

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

Other (non-serious) adverse events

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

For serious adverse events, the registry lists 54 participants at risk in the telemonitor group and 45 in usual care, with zero affected participants in each group. The separate other-adverse-event counts also list zero affected participants in both groups. These are the recorded counts; they should not be expanded into a conclusion that no adverse events of any kind occurred or that the intervention is free of risk.

The registry does not provide serious-adverse-event terms, and deaths are not reported in the record. The meaning and completeness of these counts depend on the period of safety follow-up, event definitions, collection procedures, and reporting rules, none of which are detailed. The registry also does not provide an inferential comparison of safety between groups.

Zero observed events in a group does not establish that the underlying risk is zero. A trial's ability to characterize uncommon harms depends on the amount of safety follow-up and the number of participants observed, as well as complete event ascertainment. Those details are not reported in the registry record. The counts therefore describe what was posted, not a comprehensive assessment of comparative safety.

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

The registry records a randomized comparison of telemonitoring with usual home care among adults with heart failure. For the primary combined endpoint, it posts median times of 60.0 days and 62.0 days, respectively, but does not report a sponsor-led comparative estimate or test. Those medians alone cannot show whether the time-to-event distributions differed, how precise any difference might be, or whether the groups had different event frequencies.

The secondary questionnaire summaries show group means of 34.3 and 28.3, with a recalculated unadjusted difference of 6.0. Its confidence interval includes zero, and the unadjusted p-value is 0.05. That summary is not a sponsor-reported analysis and does not establish a definitive difference. The registry does not report a threshold for interpreting the score's clinical importance, so the size of the mean contrast cannot be labeled meaningful or unmeaningful on the basis of this record alone.

These results do not establish that telemonitoring reduces hospital readmissions, emergency-department visits, or other health-service use. They also do not establish that it has no effect. The required comparative primary analysis is absent, and the record does not provide event counts or the information needed to assess censoring and follow-up. Lack of a reported analysis is not equivalent to evidence of no difference.

Likewise, the adverse-event figures are limited to the counts posted in the registry. They cannot establish comprehensive safety or rule out uncommon events. The trial's sample size and unreported follow-up and ascertainment details constrain how much can be inferred.

The most defensible reading is therefore descriptive: the registry reports group-level primary medians, secondary score summaries, and adverse-event counts, but leaves important comparative and analytic details unavailable. Conclusions about effectiveness, clinical importance, or comparative safety require evidence beyond these posted results.

13. Why This Trial Matters Statistically

This trial illustrates why a randomized label and a pair of outcome summaries do not by themselves provide a complete statistical answer. Random allocation is an important design feature, but interpretation still depends on how outcomes were analyzed, how follow-up was handled, and whether the comparative estimate and its uncertainty were reported.

The primary endpoint is time-to-event, yet the available record gives only group medians and standard deviations. For this outcome, a full comparison needs information about event timing across follow-up and about participants whose events were not observed. Without a sponsor-reported hazard ratio or another inferential comparison, readers cannot evaluate the relative pattern or its precision from the medians alone. The registry's absence of these analyses is especially important because the primary question concerns whether event timing differed between randomized groups.

The secondary score demonstrates a different issue: a recalculated mean difference can be accompanied by a nominal p-value and confidence interval, but those statistics do not replace a reported analysis plan. The p-value sits at 0.05, and the interval includes zero. The unadjusted nature of the calculation, uncertain multiplicity context, and unreported missing-data methods all affect how much weight it can bear.

The planning illustrations show how assumptions about the target effect influence prospective sample-size requirements. They are useful as planning quantities, but they cannot be used to infer observed power or to validate the original design. The original sample-size rationale is not reported.

More broadly, this record is a reminder that statistical transparency includes more than point estimates. Event counts, uncertainty intervals, analysis populations, missing-data methods, and prespecified testing strategy all help readers distinguish descriptive patterns from reliable comparative evidence. Their absence limits interpretation without proving that an unreported analysis was never performed.

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.

The most important trial-specific limitation in the available record is that the primary endpoint lacks a sponsor-reported between-group analysis. The medians are posted, but event counts, a comparative hazard ratio, a confidence interval, and a reported test are not. The registry therefore does not permit assessment of the primary estimate's precision or of the full event-time pattern.

The endpoint descriptions also leave ambiguity about the analysis timeframe. The primary outcome specifies follow-up during home-care services up to 12 months, while the brief summary describes the hypothesis over the 60 day post-hospitalization period. The record does not explain how these time references align in the reported analysis. It also does not separate readmissions from emergency-department visits, so the contribution of each component cannot be assessed.

The intervention and usual-care descriptions are brief. Monitoring procedures, participant adherence, responses to device readings, and consistency of usual care are not reported in the registry record. These details would help clarify what contrast was implemented, but should not be inferred from the intervention labels.

For the secondary score, no baseline result, change estimate, analysis population, missing-data approach, or sponsor-reported model is listed. Its unadjusted recalculation may not account for covariates or multiple testing. A clinical-importance threshold is also not reported. The adverse-event record gives affected counts but not event terms, deaths, or detailed safety ascertainment and follow-up.

Finally, the registry does not report the protocol-level sample-size justification, statistical analysis plan, allocation-concealment procedures, or analysis populations. These gaps prevent evaluation of whether the posted summaries correspond to prespecified analyses and whether all randomized participants were represented. They limit what can be concluded from the record; they do not establish that the missing procedures were absent from the study itself.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Trial of Telemonitoring in Adults With Heart Failure — NCT01393314.
• Registry record last updated 2022-08-10; status last verified 2022-03.
• Results first posted 2022-08-10.
• 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

NCT01393314 is a completed randomized, parallel-group trial sponsored by Case Western Reserve University, with enrollment of 99 adults with heart failure. It compared the Honeywell HomMed Telemonitor with usual home care that included an educational package. Masking is listed as none.

The primary endpoint was median time to hospital readmission or emergency-department visit. The registry posts group medians but no sponsor-reported comparative analysis. The secondary outcome was the Kansas City Cardiomyopathy Questionaire; its posted summaries support an unadjusted recalculation, but not a sponsor-reported result. Serious and other adverse-event counts list zero affected participants in both groups; deaths are not reported.

Important analytic details—including the primary statistical method, missing-data handling, analysis populations, multiplicity approach, and original sample-size justification—are not reported in the registry record. The posted results therefore support cautious descriptive interpretation, not a definitive comparative conclusion.