This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring (NCT00312884), a randomized phase 3 study. The primary outcome is Days Alive and Outside of Hospital.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00312884 |
| Phase | Phase 3 |
| Condition | Heart Failure |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 182 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Imperial College London |
| Results posted | Yes |
2. Clinical Question
Population
Patients with heart failure recently discharged from hospital. The registry record lists 182 participants enrolled.
Intervention
The HomMed Telemonitoring System, described as telemonitoring of signs and symptoms after discharge.
Comparator
Usual hospital and community care.
Primary question
How did days alive and outside hospital over 180 days compare between the randomized groups?
The registry hypothesis is that patients using home telemonitoring after discharge have a reduced risk of all-cause rehospitalisation compared with usual care. The primary outcome posted is related to that question but is not simply a count of readmissions: it measures days alive and outside hospital from randomisation through 180 days. It therefore reflects time spent outside hospital as well as whether participants remained alive during follow-up.
The intervention description says information from home was screened, with contact from a heart failure nurse if important changes were seen. The nurse could offer advice and might arrange a clinic visit or suggest medication alterations. The comparator is described only as usual hospital and community care. Further details about what usual care involved are not reported in the registry record.
The central statistical question is whether the observed outcome summaries support a reliable between-group conclusion. The posted medians and inter-quartile ranges describe each group, but a two-arm inferential comparison for this median-time outcome is not reported in the registry record. Consequently, the summaries alone do not establish the size or precision of a treatment effect.
3. Trial Design
This was a phase 3, randomized, parallel-group trial with no masking. The registry record lists Imperial College London as the sponsor and 182 participants enrolled. The trial status is completed. The start is recorded as 2006-05, and primary completion as 2008-09.
Participants were assigned to usual care or the telemonitoring intervention. The posted outcome summaries include 91 participants in each group. The usual-care arm is described as receiving usual hospital and community care; the intervention arm is described as receiving telemonitoring. The intervention is named the HomMed Telemonitoring System.
The primary outcome was days alive and outside hospital, measured from randomisation for 180 days. The registry specifies a median and inter-quartile range as the summary measures. The reported values are 180 days (165 to 180) for usual care and 178 days (90 to 180) for telemonitoring.
Random assignment is intended to make the groups comparable at baseline, on average, but it does not guarantee that every characteristic is balanced. With no masking, participants and those delivering the intervention knew the assigned care. General statistical considerations include the possibility that awareness of assignment can affect care, behaviour, or outcome ascertainment; the record does not describe whether any such effects occurred.
Details about the randomisation procedure, allocation concealment, protocol deviations, recruitment, baseline characteristics, and the analysis plan are not reported in the registry record. The record also does not report an interim-analysis plan or a sample-size justification for the trial. These omissions limit assessment of how the planned design was implemented and how the posted results relate to the original protocol.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Intervention Arm | Usual Care |
|---|---|---|
| STARTED | 91 | 91 |
| COMPLETED | 74 | 79 |
| NOT COMPLETED | 17 | 12 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Usual Care | Intervention Arm | Total |
|---|---|---|---|---|
| Participants analysed | 91 | 91 | 182 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 30 | 30 | 60 |
| Age, Categorical: >=65 years | Participants | 61 | 61 | 122 |
| Age, Continuous | years | 72 (SD 10.4) | 70 (SD 12.8) | 71 (SD 11) |
| Sex: Female, Male: Female | Participants | 32 | 29 | 61 |
| Sex: Female, Male: Male | Participants | 59 | 62 | 121 |
| Region of Enrollment: United Kingdom | participants | 91 | 91 | 182 |
6. Primary Endpoint
The registry lists the primary outcome as Days Alive and Outside of Hospital, measured over From date of randomisation for 180 days.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | Days |
| Endpoint classification | Time-to-Event Analysis |
The primary outcome is days alive and outside hospital, described as days alive and not admitted, from randomisation through 180 days. It combines information about survival and time spent outside hospital during the stated follow-up period. A larger value represents more days meeting that definition, while a lower value can reflect time admitted, death, or both. The registry does not provide additional rules for handling events or incomplete follow-up.
The registry summarizes this outcome with a median and inter-quartile range. The median is the central value when observations are ordered; the inter-quartile range describes the middle half of the observed values. These summaries can be useful when an outcome is skewed or has many observations near its upper limit, but they do not by themselves quantify the uncertainty in a between-group effect.
For usual care, the median was 180 days, with an inter-quartile range from 165 to 180. For telemonitoring, the median was 178 days, with an inter-quartile range from 90 to 180. The 180-day upper endpoint means the measure is bounded by the follow-up duration. The registry record does not report a two-arm test, confidence interval, or other inferential estimate for this outcome, so precision of the group comparison cannot be assessed from the posted summaries alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary-outcome summaries are medians of 180 days for usual care and 178 days for telemonitoring, each observed over the 180-day period from randomisation. The inter-quartile range is 165 to 180 days for usual care and 90 to 180 days for telemonitoring. These are descriptive summaries of the recorded groups, not an estimate of the uncertainty around a treatment effect.
The values indicate that the median was near the 180-day upper bound in both groups. The inter-quartile ranges show that the central half of observed values extended across different spans in the two arms. That pattern is a reason to avoid relying on the medians alone: a median can conceal variation elsewhere in the distribution, and the difference in spread does not itself establish a reliable group effect.
The registry record does not report a two-arm inferential comparison for this median-time endpoint. It therefore does not provide a confidence interval, p-value, or other estimate of the precision of the observed contrast. A numerical difference between the reported medians should not be treated as a recalculated treatment effect: the posted outcome is a distributional summary, and no individual-level analysis or sponsor comparison is included in the record.
The stated hypothesis concerns reduced risk of all-cause rehospitalisation. The primary outcome instead reports days alive and outside hospital. These measures are connected, but they are not interchangeable: the primary outcome incorporates survival and time outside hospital over follow-up, whereas a risk of rehospitalisation is a distinct event-based question. The registry summary does not report a result for the stated rehospitalisation hypothesis.
Interpretation is also constrained by the absence of reported information about missing outcome data, analysis populations, protocol deviations, and the prespecified statistical method. Without these details, readers cannot establish whether all randomized participants contributed to the posted summaries or how incomplete follow-up was handled. The figures describe what is posted for each arm; they do not establish that telemonitoring changed the outcome or that the groups were equivalent.
The record lists serious adverse events in both groups, including hospitalisation as the top serious term. Those counts are safety descriptions and are not a substitute for a comparative analysis of the primary outcome. No conclusion about the balance of benefits and harms can be drawn from the limited outcome information alone.
9. Statistical Methods Explained
What do the medians describe?
The median is a measure of the centre of a distribution. After values are ordered, it marks the point with half the observations on either side, subject to the conventions used for ties and even-sized samples. It is less affected by extreme values than the arithmetic mean. That can make it useful for outcomes with a skewed distribution or a concentration of observations at a boundary.
Here, the endpoint is bounded by the 180-day follow-up period, and the reported medians are 180 days for usual care and 178 days for telemonitoring. A value at the upper limit is not a statement that every participant had that value. It describes the middle of the ordered observations. The inter-quartile ranges add information about the middle half of the data: 165 to 180 days for usual care and 90 to 180 days for telemonitoring. They do not describe every observation or the uncertainty in a treatment effect.
What would an inferential comparison add?
General statistical explanation: an inferential comparison estimates how compatible the observed data are with a range of possible group effects, under a specified analysis model. A confidence interval gives a range of effect estimates that reflects sampling uncertainty under that model. A p-value, when reported, summarizes a different aspect of the evidence relative to a specified null hypothesis. Neither measure is reported for the primary endpoint in the registry record.
For a skewed or bounded endpoint, an analysis might use methods suited to the outcome’s distribution rather than assume that the group summaries follow a simple normal pattern. The precise method matters because it determines the effect being estimated and the assumptions used to quantify uncertainty. The method selected for this trial is not reported in the registry record. It would therefore be inappropriate to infer a test or confidence interval from the medians and inter-quartile ranges alone.
Why does variation matter?
General statistical explanation: over-dispersion means that observations vary more than a chosen model expects. If a model does not accommodate the actual variation, its standard errors and confidence intervals may be too small or too large, making the stated precision unreliable. For an outcome with a bounded range and potentially uneven distribution, analysts need to consider whether their method represents the observed data adequately. The posted summary does not identify a model or provide enough information to assess over-dispersion.
The inter-quartile ranges are useful descriptive evidence about spread, but they cannot reveal the full distribution, clustering, or dependence among observations. Those features can influence the appropriate analysis and its uncertainty. Individual participant data or fuller distributional summaries are not reported in the registry record.
How should planning illustrations be read?
General statistical explanation: sample-size calculations are planning tools, not results about the participants actually enrolled. The registry’s stated planning approach uses a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect defined as a fraction of the observed effect. The illustrations are based on the observed effect and do not represent observed power. They should not be read as evidence that the completed trial had a particular probability of detecting an effect.
For time-to-event outcomes, a planning calculation can concern a total number of events; other planning calculations can be expressed as participants per arm. Any such illustration depends on its assumptions, including the target effect and the analysis approach. The numerical illustration values are not reported in the registry record described for this outcome, so no planning count can be interpreted from the primary summaries alone.
What can be concluded from the posted summaries?
The summaries establish the reported medians, inter-quartile ranges, and group sizes. They do not establish an adjusted or unadjusted effect estimate, statistical significance, or precision. A recalculation from aggregate summaries would not replace the sponsor’s analysis if it were available; no sponsor-reported comparison for this endpoint is included in the registry record. Any stronger conclusion would require inferential results and fuller information about the analysis and data handling.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists four outcome measures and no secondary results posted. The primary outcome is identified as days alive and outside hospital over 180 days. A prespecified hierarchy among outcomes, a multiplicity adjustment, and the approach to interpreting multiple tests are not reported in the registry record. Without that information, it is not possible to determine how the trial’s analysis controlled the chance of false-positive findings across outcomes or analyses.
The registry record does not report the statistical analysis plan, analysis populations, or whether the primary analysis followed intention-to-treat principles. It also does not report how participants with incomplete follow-up were handled, how missing outcome values were assessed, or whether any imputation or sensitivity analyses were performed. Those choices can affect both the estimate and its precision, especially when follow-up is incomplete or differs between groups.
Details of protocol deviations, exclusions after randomisation, and adherence to the intervention are also not reported in the registry record. No interim-analysis plan is reported. These gaps do not demonstrate that such procedures were absent; they mean the registry record does not document them. As a result, the posted arm summaries cannot be fully connected to an analysis population or a prespecified inferential strategy.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Usual Care | 23 | 91 | 25.3% |
| Intervention Arm | 33 | 91 | 36.3% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Usual Care | 10 of 91 |
| Intervention Arm | 17 of 91 |
Most frequent serious adverse event terms
| Event term | Organ system | Usual Care | Intervention Arm |
|---|---|---|---|
| Hospitalisation | Cardiac disorders | 23 of 91 | 33 of 91 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Usual Care | Intervention Arm |
|---|---|---|---|
| Heart Failure Admission | Cardiac disorders | 10 of 91 | 17 of 91 |
Serious events with the highest arm-level rate: hospitalisation (36.3%).
The registry reports serious adverse events for 23 of 91 participants in usual care and 33 of 91 participants in the telemonitoring arm. It also reports other adverse events for 10 of 91 participants in usual care and 17 of 91 participants in the telemonitoring arm. Hospitalisation is listed as the top serious adverse-event term, with 36.3% reported. The denominator and the precise basis for that percentage are not reported in the registry record.
These are counts of participants affected, as represented in the registry entries; they are not, by themselves, a statistical comparison. The record does not report a confidence interval, p-value, or adjusted safety analysis for the group contrast. It also does not report death counts in the adverse-event entries. No further breakdown by event type, timing, severity beyond the serious classification, or relationship to intervention is available in the registry record.
General statistical explanation: adverse-event counts require context, including how events were defined, collected, and attributed, and whether one participant could contribute more than one event. The posted figures should therefore be read as descriptive safety information, not as a causal estimate or a complete benefit-harm assessment.
12. What the Result Does, and Does Not, Mean
The trial record documents randomized assignment of patients with heart failure recently discharged from hospital to telemonitoring or usual care. The primary outcome is days alive and outside hospital during the 180 days after randomisation. The posted medians are 180 days for usual care and 178 days for telemonitoring, with inter-quartile ranges of 165 to 180 and 90 to 180 days, respectively.
Those summaries describe the observed distributions in the two arms. They do not show whether a between-group effect is statistically distinguishable from chance, how large an effect might be under an inferential model, or how precisely it is estimated. The registry does not report the inferential comparison for this endpoint. It also does not report a result for the stated hypothesis about all-cause rehospitalisation.
The outcome should not be interpreted as a direct measure of all aspects of heart failure care, quality of life, anxiety, or value for money. The brief summary lists these as aims of the project, but results for them are not reported in the registry record. Nor do the primary outcome medians establish whether any individual participant benefited or was harmed.
Serious and other adverse-event counts are posted for both groups, but they lack a reported comparative analysis and sufficient detail to support a broader safety conclusion. The figures alone do not establish a causal difference between assigned groups.
Overall, the record permits a descriptive reading of group sizes, primary-outcome medians and ranges, and adverse-event counts. It does not support a definitive claim that telemonitoring changed days alive and outside hospital, reduced rehospitalisation, or had a particular balance of benefits and harms. These limits reflect missing inferential and analysis details in the registry record, not proof that no further analyses exist elsewhere.
13. Why This Trial Matters Statistically
This trial illustrates why endpoint definitions and statistical summaries must be read together. The registry hypothesis concerns the risk of all-cause rehospitalisation, while the posted primary outcome is days alive and outside hospital over 180 days. The latter includes both survival and time not admitted, so its interpretation is broader than a simple rehospitalisation count. A reader should keep that distinction in view when relating the stated hypothesis to the posted result.
It also demonstrates the limits of comparing medians without an estimate of uncertainty. The reported medians are 180 days and 178 days, while the inter-quartile ranges span 165 to 180 days and 90 to 180 days. These summaries convey central tendency and some spread, but they do not establish the precision or statistical evidence for a group effect. An inferential analysis and its assumptions are needed for that purpose.
The endpoint is bounded at the follow-up duration, and the medians sit near that upper bound. General statistical interpretation of bounded outcomes needs care: a central value can be constrained by the measurement window, and the distribution’s shape can matter to analysis. The posted medians and inter-quartile ranges are useful, but they cannot substitute for fuller distributional or inferential results.
Finally, the record shows how registry reporting affects reproducibility. The randomised parallel-group design and outcome summaries are documented, but the analysis plan, missing-data methods, analysis populations, multiplicity approach, and comparative result are not reported. Without those details, readers can describe the posted data but cannot independently assess the planned inferential procedure or its precision.
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 primary limitation for interpretation is that no inferential comparison is reported for the primary endpoint. The medians and inter-quartile ranges do not supply a confidence interval or p-value, and they do not identify an effect estimate under a specified model. The posted endpoint summaries therefore support description, not a conclusion about a treatment effect.
The record does not report missing-data handling, analysis populations, participant flow, protocol deviations, adherence, or the statistical analysis plan. It is not possible to determine from the registry record whether all randomized participants were included in the outcome summaries or how incomplete observations were treated. Baseline characteristics are also not reported in the information available for this record, limiting assessment of the enrolled groups’ comparability beyond random assignment.
The trial was unmasked. General statistical considerations include the possibility that knowledge of assignment may influence behaviour, care, or outcome assessment, although the registry record does not describe whether this occurred. The record also does not provide details about allocation concealment or the randomisation procedure.
The stated hypothesis concerns all-cause rehospitalisation, but the posted primary summary is days alive and outside hospital. A separate result for rehospitalisation is not reported in the registry record. Results for the additional aims mentioned in the brief summary, including anxiety, quality of life, and value for money, are also not reported. Safety counts lack a comparative inferential analysis and fuller event definitions. These reporting limits prevent a complete assessment of efficacy, safety, and generalisability.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring — NCT00312884.
- Registry record last updated 2016-05-30; status last verified 2007-11.
- Results first posted 2016-05-30.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes Home-HF, a completed, phase 3 randomized parallel-group trial with no masking, sponsored by Imperial College London. It lists 182 participants enrolled and compares usual care with the HomMed Telemonitoring System after hospital discharge for heart failure. The trial start is recorded as 2006-05 and primary completion as 2008-09.
The primary outcome is days alive and outside hospital from randomisation for 180 days, summarized by medians and inter-quartile ranges. The posted values are 180 days (165 to 180) for usual care and 178 days (90 to 180) for telemonitoring, with 91 participants in each arm. A two-arm inferential comparison is not reported in the registry record. Serious and other adverse-event counts are listed for both groups, but the record does not report a comparative safety analysis or the other planned outcome results.