Evaluating the Value of Telehealth for Care of Children With Medical Complexity: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluating the Value of Telehealth for Care of Children With Medical Complexity (NCT02849938), a randomized na study. The primary outcome is Frequency of In-person Health Care Encounters.

2. Clinical Question

The study also aimed to compare the impact of the device and telephone assessment on patient management and user satisfaction. Provider and parent surveys are listed as secondary outcomes. Those aims make the study broader than a test of encounter frequency alone: feasibility, usability, management, and user experience are part of its stated rationale. However, aims and outcome labels do not establish what was ultimately measured or found. The record lists 24 participants as the enrollment, but does not report participant characteristics or explain how many were included in any outcome analysis.

3. Trial Design

The registry identifies this as a randomized, open-label, parallel-group study. The listed groups are Control Group, described as usual care, and Telemedicine Group, assigned the TytoCare Device. Random allocation is intended to make the groups comparable with respect to both measured and unmeasured characteristics, on average. Whether that goal was achieved in this study cannot be assessed without group characteristics and outcome data.

The study is listed as completed, with enrollment of 24. Its start is recorded as 2016-09 and its primary completion date as 2017-01-31. The study phase is listed as NA. The registry names Wake Forest University Health Sciences as sponsor and cerebral palsy as a condition. The record does not provide further details about eligibility criteria, recruitment, allocation concealment, or the randomization procedure.

Masking is listed as none. In an unmasked study, participants and care providers may know which approach is being used. That can be relevant when outcomes involve satisfaction, provider judgments, or decisions about care, although the record does not report whether or how such effects were assessed. A parallel design assigns participants to a group for comparison rather than describing a crossover between approaches; the record does not give further operational details about treatment delivery or follow-up.

The stated aims include evaluating feasibility and usability of a home telehealth device, as well as comparing patient management and user satisfaction with telephone assessment. Those aims are distinct from the primary outcome label concerning in-person encounters. Because the endpoint description refers instead to hospital days, the exact primary endpoint needs clarification before the design can be interpreted as a definitive test of a particular measure.

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 Frequency of In-person Health Care Encounters, measured over 3 months.

The primary outcome is titled Frequency of In-person Health Care Encounters, with a timeframe of 3 months and a unit of days. Its description, however, says that hospital day length of stay is reported as the total number of hospital days in the group. Encounter frequency and total hospital days are not interchangeable measures: one concerns how often in-person care occurs, while the other concerns time spent in hospital. The registry record does not clarify which quantity was actually collected or how it was summarized.

Both types of measure can be relevant to evaluating a home telehealth approach, but they answer different questions. Encounter frequency concerns utilization events; hospital days reflect duration of hospitalization. A clearly specified endpoint helps readers understand what an observed difference would mean, how the measure should be analyzed, and what exposure period applies. The 3-month timeframe is stated, but the record does not explain the counting rules, whether repeated encounters were included, or how hospital days were attributed to participants.

No primary-outcome values, group estimates, uncertainty intervals, or statistical test are reported in the registry record. Consequently, the record cannot establish the magnitude or precision of any difference in this endpoint. The mismatch between the title and description also prevents a firm interpretation of what a future comparison would represent.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization assigns participants to study groups by chance. In general, it is used to reduce systematic differences between groups that could otherwise influence a comparison. Its benefit depends on how the sequence was generated and whether group assignments were concealed until enrollment decisions were complete. Those procedures are not reported in the registry record. The record identifies the study as randomized but does not document the method used.

What does the parallel design mean?

In a parallel-group design, the groups receive their assigned approaches during the study and are compared across the same general follow-up period. The registry names a Control Group receiving usual care and a Telemedicine Group receiving the TytoCare Device. It does not describe whether participants could switch approaches, how device use was monitored, or how consistently the approaches were delivered. Such details matter because differences in implementation can affect the interpretation of group outcomes.

What does open-label mean for interpretation?

Masking is listed as none. In general, masking means keeping participants, clinicians, or outcome assessors unaware of assigned treatment. When assignment is known, expectations or behavior can influence care decisions, survey answers, or judgments about usability and satisfaction. This is especially relevant to subjective measures. More objective measures may be less sensitive to expectations, but their definitions and collection procedures still need to be clear. The registry record does not describe outcome assessor masking or safeguards against measurement differences.

How should a count outcome be analyzed?

The primary outcome is categorized as a count, but its title and description point to different possible quantities. In general, count outcomes can be analyzed with models designed for event counts, provided the counted event and observation time are defined. If participants have different amounts of time under observation, the analysis may need to account for that difference. Over-dispersion occurs when variability in counts is greater than assumed by a simple count model; failing to account for it can make uncertainty estimates too narrow. These are general considerations, not a description of the method used in this study. The registry record does not report a statistical model or analysis plan.

For hospital days, the measure may have a different distribution from a count of separate encounters. The right method depends on how the measure was recorded, how many participants had no hospital days, the shape of the observations, and whether each participant's experience was summarized individually or only by group. The record says total hospital days in the group, but gives no participant-level or group-level outcome values and no further method details. It is therefore not possible to identify which approach, if any, was used.

What do estimates and confidence intervals communicate?

In general, an estimate describes the observed effect in the study, while a confidence interval describes the range of values compatible with the data under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval; an interval spanning values that would imply different practical interpretations leaves more uncertainty. A p-value addresses compatibility with a specified null model, not the probability that a treatment works or that a result is true. The registry record reports no estimate, confidence interval, or p-value for the primary outcome, so none of these aspects can be assessed.

What is the role of the planning illustration?

The stated sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. In general, such calculations ask how many participants per arm would be needed under specified assumptions. They are planning illustrations, not observed power, and do not establish that a study was adequately sized. The registry record does not report the trial's own design justification or a sample-size rationale. Since no primary outcome effect is reported, the planning assumptions cannot be used to infer the result or its precision.

For a time-to-event outcome, sample-size methods may be based on the total number of events; that framework is not indicated by the primary outcome description in this record. The record does not report a time-to-event analysis. More generally, calculations depend on the endpoint, anticipated effect, variability, allocation, and analysis method. They cannot compensate for an unclear endpoint or missing outcome results.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and Provider Survey and Parent Survey as secondary outcomes. Its study aims also mention feasibility, device usability, patient management, and user satisfaction. Considering several outcomes raises a general multiplicity issue: the more comparisons made, the more likely it is that at least one result may appear noteworthy by chance if all are interpreted without regard to the number of tests. A prespecified hierarchy or adjustment can address some multiplicity concerns, but neither is reported in the registry record.

The record lists 3 outcome measures and 0 analyses. It does not describe which outcomes were included in an analysis, whether the primary outcome was specified before results were examined, or whether any multiplicity strategy was planned. It also does not report interim analyses or a statistical analysis plan. Their status is not reported in the registry record.

Missing-data procedures and analysis populations are also not reported in the registry record. The enrollment is listed as 24, but the record does not state how many participants were randomized, completed follow-up, contributed to each outcome, or were excluded from analyses. It gives no account of missing survey responses, incomplete follow-up, or reasons for missing measurements.

These omissions limit interpretation because the handling of missing observations can affect group comparisons, and analysis populations answer different questions. For example, an analysis based on assigned groups differs in purpose from one restricted to participants with complete measurements. Without the relevant definitions and counts, readers cannot assess the extent or potential impact of missing data or determine which population an outcome estimate would represent.

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 lists no serious adverse events in the Control Group, with 9 participants at risk, and no serious adverse events in the Telemedicine Group, with 15 participants at risk. It also lists no other adverse events in either group and no deaths in either group. These are the adverse-event figures recorded for the groups.

A recorded count of zero means that the registry reports no events in that category; it does not establish that the risk is absent. The record does not describe how adverse events were defined, how actively they were monitored, the duration of safety observation, or whether all participants contributed complete safety follow-up. The listed numbers at risk should not be interpreted as proof that every participant was observed for the same length of time.

These safety listings do not provide a statistical comparison or an estimate of uncertainty. With no event counts beyond zeros in the registry, the record cannot quantify a difference in safety between the approaches. The figures also do not address the primary outcome of healthcare encounters or hospital days. Safety and effectiveness are separate questions, and the adverse-event listings alone do not answer either the primary endpoint question or the study's broader feasibility and usability aims.

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

The registry record describes a randomized comparison of a TytoCare telehealth device with usual care, and its study summary frames the comparator as traditional telephone assessment. It outlines aims related to feasibility, usability, patient management, and satisfaction. Those details show what the study set out to examine, but they do not establish the result of the comparison.

No primary-outcome estimates or survey findings are reported in the registry record. There is no reported direction or magnitude of an effect, no confidence interval to indicate precision, and no test result to assess statistical compatibility with a null hypothesis. The endpoint title and description also differ, leaving uncertainty about whether the intended measure was encounter frequency or total hospital days.

Accordingly, the posted information cannot show that TytoCare changed healthcare use, patient management, or user satisfaction. It also cannot show that the groups were equivalent. A lack of reported results should not be read as evidence of no effect; it means the registry record does not contain the results needed to evaluate that question.

The trial's randomized design is relevant to how a completed comparison could be interpreted, but conclusions would still depend on the actual outcomes, completeness of follow-up, analysis population, and statistical methods. None of those outcome-analysis details is reported in the registry record. The listed adverse-event counts are descriptive safety entries and do not fill the gap in primary outcome reporting.

13. Why This Trial Matters Statistically

This study addresses a statistical question that is broader than whether a device can transmit clinical information. The stated aims combine feasibility and usability with patient management and user satisfaction. These outcomes differ in how they are measured and interpreted. A device may be feasible to use, for example, without that alone establishing a change in healthcare utilization. Keeping these questions distinct is important when interpreting a clinical study.

The primary outcome label illustrates why precise measurement definitions matter. Frequency of in-person encounters and total hospital days represent different constructs and can require different summaries and analytic methods. When a registry record does not resolve that distinction, readers cannot map a numerical result to a clear clinical question, even if an estimate were posted.

The study is identified as randomized and parallel, which supplies a useful framework for comparing approaches. At the same time, its open-label status, the potential subjectivity of survey outcomes, and the absence of reported outcome analyses all matter for interpretation. Statistical design is not only the choice of a test; it includes defining the outcome, planning the analysis, documenting missing data, and communicating uncertainty.

Registry entries are valuable for identifying study aims and basic design features, but a record without outcome estimates cannot support an assessment of effect size or precision. This distinction is important for researchers and clinicians reading trial records: a completed status is not itself a results report. The available information helps frame the questions to ask of any fuller report without resolving the trial's findings.

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 main limitation of the registry record is the absence of primary and secondary outcome results. Without group estimates and measures of uncertainty, the direction, magnitude, and precision of any comparison are unknown. The record lists 0 analyses, but does not establish whether analyses were conducted outside the registry.

The primary outcome is not described consistently: its title concerns frequency of in-person encounters, while its description concerns total hospital days. The record does not clarify the operational definition, counting rules, or group-level calculation. This ambiguity prevents a confident interpretation of what the primary measure represents.

Participant-level information is limited. Enrollment is recorded as 24, but baseline characteristics, eligibility details, randomized counts, follow-up completeness, and analysis populations are not reported in the registry record. The record also does not describe how usual care was delivered, how device use was monitored, or how the telephone assessment was implemented.

Further limitations include no reported randomization procedure, allocation concealment, statistical analysis plan, missing-data strategy, or multiplicity approach. Masking is listed as none, but the record does not say whether outcome assessment was masked. The safety entries contain no recorded events, but monitoring methods and duration are not described. These gaps do not demonstrate flaws in the conduct of the trial; they limit what can be evaluated from the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluating the Value of Telehealth for Care of Children With Medical Complexity — NCT02849938.
• Registry record last updated 2024-10-08; status last verified 2017-04.
• Results first posted 2019-02-05.
• 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

NCT02849938 is a completed randomized, open-label, parallel-group study sponsored by Wake Forest University Health Sciences. It lists enrollment of 24 and compares a TytoCare Device group with a Control Group described as usual care. The study summary frames the comparison as TytoCare versus traditional telephone assessment for children with medical complexity in the home environment.

The primary outcome is titled Frequency of In-person Health Care Encounters, with a 3-month timeframe, but its description refers to total hospital days. Provider Survey and Parent Survey are listed as secondary outcomes. The record reports no outcome analyses or primary results, and does not clarify the endpoint discrepancy. Adverse-event listings report no serious or other adverse events and no deaths in either group. The registry record supports a description of study aims and design, but not an assessment of the trial's outcome effects.