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 Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF) (NCT03562247), a randomized na study. The primary outcome is The Number Hospitalization Events Resulting From a Respiratory Illness.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03562247 |
| Phase | NA |
| Condition | Idiopathic Pulmonary Fibrosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 31 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Vanderbilt University Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Newly diagnosed patients with idiopathic pulmonary fibrosis (IPF). The registry record lists an enrollment of 31, although the endpoint arm entries list their own participant counts and do not account for every enrolled participant.
Intervention
One arm received usual care with structured telenursing. A second received usual care with telenursing and remote monitoring using a handheld spirometer and pulse oximeter, with daily measurements reported through a secure electronic platform for review by the telenursing team.
Comparator
Usual care for IPF. The registry describes this as continuing the healthcare given in routine management of the lung disease.
Primary question
How many hospitalization events resulting from respiratory illness were recorded in each arm over the period from baseline to 21 months? The registry presents event counts for the three arms, but does not post an inferential comparison between them.
The registry describes a randomized, parallel-group study with no masking. Its stated rationale is that structured nurse contact and home monitoring might influence respiratory events, therapy compliance, and quality of life in people newly diagnosed with IPF. Those statements describe the study's motivation, not findings from the trial.
The primary endpoint is a count of hospitalization events attributed to respiratory illness. The record also lists seven secondary outcomes, including respiratory events, acute exacerbations, time from diagnosis to first respiratory-illness hospitalization, dyspnea, depression, anxiety, and change in forced vital capacity. Results are posted for the primary count, but results for those secondary outcomes are not reported in the registry record. The central statistical question is therefore descriptive: what event counts were recorded in the three arms, and how much uncertainty can be attached to any difference? Since no comparison estimates or uncertainty measures are posted, the registry results do not answer the latter question.
3. Trial Design
This was a randomized, parallel-group study with three arms: usual care for IPF, telenursing, and telenursing with remote monitoring. The registry lists masking as none, so the study is described as unmasked. Its phase is listed as not applicable. Vanderbilt University Medical Center is named as the sponsor.
The registry lists enrollment of 31. For the primary endpoint, it reports 7 participants in usual care, 10 in telenursing, and 9 in telenursing with remote monitoring. These are the arm counts attached to the posted endpoint results. The registry record does not explain the difference between the overall enrollment and those endpoint arm counts, so no reason for that difference can be inferred.
The usual-care arm continued the care used for management of IPF. The telenursing arm added structured calls from a nurse practitioner and/or case manager, described as more frequent earlier in diagnosis and later directed toward symptom management. The combined intervention arm added home measurements with a handheld spirometer and pulse oximeter, with daily readings reported electronically to the telenursing team.
The study start date is 2018-08-01, and the primary completion date is 2020-05-26. Its status is listed as terminated. A reason for termination, recruitment history, and any changes to the planned design are not reported in the registry record. The record does not report a sample-size justification or the intended statistical analysis plan. It also does not describe the randomization procedure or whether allocation was concealed.
These details define the comparison the study set out to make, but they do not establish that the arms were comparable in every respect or that every randomized participant contributed to the endpoint. Those questions require participant flow, baseline characteristics, and analysis-population details, which 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
| Stage | Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | Telenursing | Telenursing and Remote Monitoring |
|---|---|---|---|
| STARTED | 10 | 11 | 10 |
| COMPLETED | 7 | 10 | 9 |
| NOT COMPLETED | 3 | 1 | 1 |
Reasons for not completing this period:
| Reason | Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | Telenursing | Telenursing and Remote Monitoring |
|---|---|---|---|
| Lost to Follow-up | 3 | 1 | 1 |
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 of Idiopathic Pulmonary Fibrosis (IPF) | Telenursing | Telenursing and Remote Monitoring | Total |
|---|---|---|---|---|---|
| Participants analysed | 10 | 11 | 10 | 31 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 | 1 | 3 | 7 |
| Age, Categorical: >=65 years | Participants | 3 | 6 | 5 | 14 |
| Sex: Female, Male: Female | Participants | 3 | 3 | 3 | 9 |
| Sex: Female, Male: Male | Participants | 4 | 4 | 5 | 13 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 | 7 | 8 | 22 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 3 | 1 | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 7 | 6 | 8 | 21 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 3 | 1 | 4 |
| Region of Enrollment: United States | Participants | 10 | 11 | 10 | 31 |
6. Primary Endpoint
The registry lists the primary outcome as The Number Hospitalization Events Resulting From a Respiratory Illness, measured over Baseline to 21 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of hospitalization events resulting from a respiratory illness, measured from baseline to 21 months. It is a count outcome: each qualifying hospitalization event contributes to the total. The endpoint is not a measure of the number of participants hospitalized, and the posted record does not state whether multiple events for one participant were counted separately or how events were classified.
Hospitalization counts are used to describe serious respiratory events that lead to inpatient care. In a study of IPF, such a measure can address whether respiratory-illness hospitalizations were recorded during the stated follow-up period. However, the count alone does not describe why an event occurred, how long a hospitalization lasted, or whether it was judged related to IPF or to an intervention.
The posted arm results are 1 event among 7 participants in usual care, 0 among 10 participants in telenursing, and 0 among 9 participants in telenursing with remote monitoring. These are descriptive counts. No confidence intervals, adjusted estimates, or statistical tests are posted, and the registry does not explain whether follow-up time was complete and comparable across participants. Without those details, the counts do not quantify the precision of an arm-to-arm contrast.
The registry record lists seven secondary outcomes, but their results are not reported. Consequently, the primary count is the only posted outcome result described in this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome is sparse: the usual-care arm has 1 hospitalization event resulting from respiratory illness, while the telenursing and telenursing-with-remote-monitoring arms each have 0. The corresponding endpoint participant counts are 7, 10, and 9. These values describe what the registry reports; they are not an estimate of a treatment effect, and they do not establish that one approach caused more or fewer events.
Counts this small are difficult to interpret as evidence of a difference. A count can vary substantially when only a few events are observed, and a zero count does not show that the underlying event rate is zero. The registry record supplies no interval estimates or other uncertainty measures, so the precision of the observed counts cannot be assessed from the posted result alone. Nor does it report a formal comparison across the three arms.
The endpoint is reported as a total number of events rather than as an event rate or a time-to-first-event measure. The registry does not report exposure time for each participant, completeness of follow-up, or the method used to handle more than one event in the same participant. Those details matter because participants may contribute different amounts of observation time, and repeated events can affect how count outcomes should be analyzed.
The arm counts attached to the endpoint do not equal the registry's overall enrollment when considered together. The reason is not reported in the registry record. It is therefore not possible to determine from the posted results whether the discrepancy reflects missing endpoint data, exclusions, differences between enrollment and analysis populations, or another explanation. No such explanation should be assumed.
The study status is listed as terminated, but the reason for termination is not reported in the registry record. The record also does not report a sample-size justification or the analysis plan. Without those details, the sparse counts cannot be judged against a prespecified target, and it is not possible to know whether the posted outcome was analyzed as originally intended.
The record lists secondary outcomes concerning respiratory events, exacerbations, time to first hospitalization, symptoms, mental health, and forced vital capacity. Their results are not reported. The primary count therefore cannot stand in for those outcomes, and it cannot show whether any change occurred in symptoms, lung function, or quality of life. The results are best read narrowly: a small number of respiratory-illness hospitalization events were recorded in the usual-care arm, and none were recorded in either telenursing arm, among the participants listed for this endpoint. The data as posted do not establish the size, precision, or cause of a difference.
9. Statistical Methods Explained
What kind of outcome is this?
The primary outcome is a count: the number of hospitalization events resulting from respiratory illness during the period from baseline to 21 months. General statistical explanation: counts take nonnegative integer values and often have distributions that are not symmetric, especially when the event is uncommon. A count model may be considered when researchers want to compare groups, but the model and its assumptions must match the design and the way events were collected. The registry does not report which model, if any, was planned or used.
For a count comparison, the number of participants alone may not fully describe the information available. General explanation: if follow-up duration differs, an event rate that accounts for time at risk may be more informative than raw totals. If some participants can experience repeated events, a method may also need to account for dependence among events from the same participant. The registry does not report participant-level follow-up time, whether recurrent events were counted, or an exposure-adjusted analysis.
Why does over-dispersion matter?
General explanation: a simple count model may assume that the variability in counts follows a particular relationship to the average count. Over-dispersion means the observed variability is greater than that assumption allows. If over-dispersion is present but ignored, estimated uncertainty can be too small and statistical tests can be misleading. Assessing it requires data and a specified analysis; the registry does not report such an assessment. With only the posted arm totals, the amount of variation between participants cannot be evaluated.
What can randomization establish?
Random allocation is intended to make comparison groups similar on average with respect to measured and unmeasured characteristics before treatment begins. General explanation: randomization supports causal interpretation when allocation is implemented as intended, follow-up and outcome ascertainment are handled appropriately, and the analysis preserves the randomized comparison. The record identifies the study as randomized, but does not report the allocation procedure, concealment, baseline characteristics, participant flow, or analysis populations. The label alone does not resolve those questions.
The design is parallel, meaning the registry describes three separate arms rather than a crossover arrangement. The registry lists no masking. Lack of masking can matter when outcomes depend on subjective judgment or when knowledge of the assigned approach affects care or reporting. This endpoint concerns hospitalization events, but the record does not describe event adjudication or whether outcome assessors were independent of treatment assignment.
What would an inferential comparison add?
An estimate contrasting arms would describe the magnitude and direction of a difference under a defined statistical method. A confidence interval would convey the range of values compatible with the data and method, subject to the model's assumptions. A p-value would address compatibility with a specified null hypothesis, not the probability that an intervention works. These are general concepts; the registry record posts no comparison estimate, confidence interval, or p-value for this endpoint.
There are three arms, so a complete analysis would need to clarify which contrasts were of interest, such as each intervention against usual care or a comparison between the two intervention arms. The registry does not report a contrast plan or a statistical analysis plan. It would be inappropriate to select a contrast after seeing the counts and treat it as prespecified.
How should planning illustrations be understood?
The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the described planning quantity is the total number of events; for other outcomes, it is participants per arm. These are planning conventions, not observed results and not the trial's own design justification. Specific planning counts and a protocol-based sample-size rationale are not reported in the registry record.
General explanation: a sample-size calculation depends on the assumed effect, variability, significance level, power target, allocation, and analysis method. A planning illustration based on an observed effect should not be described as observed power. It also cannot show that a study was adequately sized unless the assumptions and planned design are appropriate. The record does not provide its own sample-size justification.
Overall, the posted values support a descriptive account of the recorded event counts. They do not support a reproducible inferential analysis because the model, comparison plan, participant-level data, and uncertainty estimates are not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven secondary outcomes alongside the primary hospitalization-event count. These include respiratory events, acute exacerbations, time to first hospitalization, dyspnea, depression, anxiety, and change in forced vital capacity. Their results are not reported in the registry record. No plan for controlling multiplicity across outcomes or across comparisons is reported either.
General explanation: when multiple outcomes or group contrasts are tested, the chance of at least one apparently unusual result can increase. A prespecified hierarchy, adjustment procedure, or clearly descriptive approach can help readers understand how multiple questions were handled. Without a reported plan and results, it is not possible to determine whether multiplicity was addressed or how it should affect interpretation.
Missing-data methods, reasons for missing outcomes, and participant disposition by arm are not reported in the registry record. The overall enrollment is 31, while the primary endpoint entries list 7 participants for usual care, 10 for telenursing, and 9 for telenursing with remote monitoring. The record does not explain the difference between those enrollment and endpoint figures. It also does not say whether the endpoint counts include all randomized participants, only participants with available outcome data, or another analysis population.
General explanation: intention-to-treat analysis retains participants in their randomized groups and can preserve the benefits of randomization, while other analysis populations answer different questions and may introduce bias if membership depends on post-randomization events. The registry record does not report which population was used. It also does not describe imputation, sensitivity analyses, or how incomplete follow-up was handled. These omissions limit assessment of both the validity and generalizability of the posted counts.
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 of Idiopathic Pulmonary Fibrosis (IPF) | 1 | 7 | 14.3% |
| Telenursing | 0 | 10 | 0.0% |
| Telenursing and Remote Monitoring | 0 | 9 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | 0 of 7 |
| Telenursing | 0 of 10 |
| Telenursing and Remote Monitoring | 0 of 9 |
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 of Idiopathic Pulmonary Fibrosis (IPF) | 0 of 7 |
| Telenursing | 0 of 10 |
| Telenursing and Remote Monitoring | 0 of 9 |
Most frequent serious adverse event terms
| Event term | Organ system | Usual Care of Idiopathic Pulmonary Fibrosis (IPF) | Telenursing | Telenursing and Remote Monitoring |
|---|---|---|---|---|
| Pulmonary embolus | Respiratory, thoracic and mediastinal disorders | 1 of 7 | 0 of 10 | 0 of 9 |
Serious events with the highest arm-level rate: pulmonary embolus (14.3%).
The registry reports serious adverse events for each arm. In usual care, 1 of 7 participants is listed as having a serious adverse event; in telenursing, 0 of 10; and in telenursing with remote monitoring, 0 of 9. No deaths are listed in any arm, and no other adverse events are listed in any arm. The most frequently listed serious-event term is pulmonary embolus, reported as 14.3%.
These are descriptive safety figures. The registry does not provide a comparative statistical analysis, confidence intervals, event timing, or information about whether each event was considered related to an intervention. The record also does not clarify the relationship between the listed serious-event term and the arm-specific serious-event entries. The term and percentage should therefore be read as reported, without assigning it to an arm or inferring causation.
A zero count in an arm does not establish that an event could not occur, particularly when the number of participants listed is small. Conversely, an event occurring during a study does not by itself show that the study intervention caused it. The posted safety counts do not support a conclusion about comparative safety.
12. What the Result Does, and Does Not, Mean
The posted result establishes a limited descriptive fact: for the primary outcome, the registry records 1 respiratory-illness hospitalization event in usual care, 0 in telenursing, and 0 in telenursing with remote monitoring. The associated endpoint arm counts are 7, 10, and 9, respectively. This is the full scope of what can be stated from the primary outcome data without additional analysis.
The counts do not show that telenursing or remote monitoring caused a change in hospitalization risk. They do not establish the magnitude or precision of a treatment effect, since no inferential comparison or uncertainty interval is posted. Nor do they establish that the event rate was zero in either intervention arm. The record does not report follow-up completeness or time at risk for each participant.
The study's stated rationale includes possible effects on hospitalization, therapy compliance, and quality of life. Those are objectives or motivations, not results. The registry lists secondary outcomes relevant to respiratory events, symptoms, mental health, and lung function, but their results are not reported. The primary hospitalization count cannot answer those other questions.
The record identifies the trial as terminated but does not give a reason. It also does not report the analysis plan, sample-size justification, missing-data approach, or analysis population. Those omissions make it difficult to assess whether the results were analyzed as intended and how representative the endpoint counts are of the randomized participants.
Accordingly, the most defensible interpretation is narrow and descriptive. The posted record documents few hospitalization events and no inferential analysis. It does not establish a beneficial, harmful, or equivalent effect of any arm, and it does not provide enough information to quantify uncertainty or explain the difference between enrollment and endpoint participant counts.
13. Why This Trial Matters Statistically
This trial is statistically informative because it illustrates the distance between a recorded count and a reliable estimate of a group difference. The primary outcome is clinically interpretable as a count of respiratory-illness hospitalization events, but the registry posts only sparse totals by arm. Without an estimate and uncertainty measure, readers cannot assess how compatible the observed counts are with a range of possible underlying effects.
The three-arm design also makes the comparison question important. Telenursing and telenursing with remote monitoring are distinct approaches, and each could be compared with usual care or with the other intervention arm. The registry record does not identify a planned set of contrasts. Specifying comparisons in advance helps distinguish the main study question from exploratory comparisons after results are known.
The difference between the overall enrollment and the endpoint arm counts is another statistical issue, not merely a reporting detail. Participant flow and analysis-population information would help show who contributed data and why. Those details are particularly important in a small trial, where each participant can have substantial influence on a count outcome.
Finally, the record lists seven secondary outcomes but does not report their results or explain how multiple outcomes were handled. Clear reporting of outcome definitions, follow-up, missing data, and analysis methods would make the findings easier to interpret and reproduce. The posted record is useful for identifying the trial question and the observed primary counts, while also showing why those counts alone cannot establish a comparative effect.
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 result is based on a small set of endpoint observations, with only one event recorded across the three arms. Such sparse data provide limited information about variation and uncertainty. The registry does not post confidence intervals, statistical tests, or effect estimates, so precision cannot be assessed.
The record lists enrollment of 31, but the arm counts attached to the primary endpoint are 7, 10, and 9. The reason those endpoint counts differ from overall enrollment is not reported in the registry record. Participant flow, reasons for non-contribution, and the analysis population are also not reported, leaving the completeness and representativeness of the endpoint data unclear.
The study status is terminated, but the reason and any impact on recruitment or follow-up are not reported. The record does not describe the randomization procedure, allocation concealment, baseline characteristics, event adjudication, or outcome ascertainment. It also does not state how recurrent hospitalizations, differing follow-up time, or missing endpoint data were handled.
No statistical analysis plan, sample-size justification, or multiplicity strategy is reported. Results for the seven secondary outcomes are not reported. The record therefore cannot support conclusions about those outcomes or show whether the primary count was the only analysis performed. These limitations concern what the registry reports; they do not establish that any particular procedure was or was not carried out outside the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF) — NCT03562247.
- Registry record last updated 2024-01-16; status last verified 2023-03.
- Results first posted 2024-01-16.
- 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 describes a randomized, unmasked, parallel-group trial in newly diagnosed patients with IPF, comparing usual care with telenursing and with telenursing plus remote monitoring. Enrollment is listed as 31, the status as terminated, and the primary completion date as 2020-05-26.
The primary endpoint is the number of respiratory-illness hospitalization events from baseline to 21 months. The endpoint results are 1 event among 7 participants in usual care, 0 among 10 in telenursing, and 0 among 9 in telenursing with remote monitoring. No inferential analysis is posted. Results for the seven secondary outcomes, the reason for termination, the sample-size justification, and the statistical analysis plan are not reported in the registry record.