Implementing 3-Step Workout for Life in Home Health: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Implementing 3-Step Workout for Life in Home Health (NCT04709783), a na na study. The primary outcome is Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care.

2. Clinical Question

Statistically, the central question is whether the program can be adapted and delivered in this home health setting and what outcome measurements the study records. The registry does not report a comparator, a randomized treatment contrast, or numerical results for the primary measure. The study therefore cannot establish whether an observed change would be attributable to the program rather than other care or changes over time.

3. Trial Design

This is a single-group implementation study of the 3-Step Workout for Life program in home health. The sponsor is the University of Florida. The record lists the study phase as NA, allocation as NA, and masking as none. Enrollment is 10. Participants in the implementation arm were to receive the program alongside other rehabilitation services based on the plan of care.

The project’s stated purpose is to study adaptation and implementation in a local home health agency. Learning cycles were planned to adjust treatment dose and delivery mode. The specific aim is to evaluate implementation-related clinical and patient outcomes. The primary outcome is a mean OASIS self-care ratio at discharge, with the timeframe described as discharge, on average 2 months. Secondary outcomes include OASIS mobility, EuroQoL, and the Activity Measure of Post-Acute Care-Home Health Version.

The registry lists a start date of 2022-05-26 and a primary completion date of 2023-04-03. Its status is terminated. The reason for termination and any details about how the study proceeded are not reported in the registry record. The record does not describe a randomized allocation or a separate control group; accordingly, this is not a randomized comparison. The intervention arm’s care also included other rehabilitation services, so an outcome cannot be attributed to the program alone from a simple before-and-after or end-of-care description.

Details of the protocol, recruitment, delivery fidelity, and analysis procedures are not reported in the registry record. The available design information supports a description of the intended intervention and measured outcomes, but not a detailed account of how implementation varied across learning cycles or how the study team analyzed the data.

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.

Before assignment: Of 10 enrolled patients, all received the modified 3-Step Workout for Life program.

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 Ratio OASIS (Outcome and Assessment Information Set) Items: Self-care, measured over Discharge, on average 2 months.

The primary endpoint is the Ratio OASIS Items: Self-care, recorded as a mean with standard deviation. The measure uses OASIS assessments of seven activities: eating, oral hygiene, toileting hygiene, upper body dressing, lower body dressing, showering or bathing, and putting on or removing footwear. Each attempted activity is scored on a six-point scale, from 1 for totally dependent to 6 for totally independent. The ratio is calculated by dividing the sum of attempted activity scores by the maximum possible total for the activities attempted.

The stated score range is 0.17, representing total dependence across self-care activities, to 1, representing total independence. A higher ratio indicates greater ability to perform self-care. Using a ratio allows the measure to account for the set of activities attempted, rather than treating unattempted activities as if they had a score. OASIS self-care is relevant to a home health study because it describes independence in daily activities, an outcome connected to the project’s stated interest in clinical and patient outcomes.

The assessment timeframe is discharge, on average 2 months. That wording describes the planned measurement point; it does not establish the actual follow-up time for each participant. The observed mean, standard deviation, participant-level completeness, and any change from an earlier assessment are not reported in the registry record. Thus the endpoint’s definition and intended timing are available, but its numerical result and precision cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a single-group design estimate?

In general, a single-group study describes outcomes among participants who receive an intervention or care package. If an outcome is measured at one time point, the mean and standard deviation describe the observed distribution at that time. If repeated measurements are collected, a within-person change can be estimated, but that requires both measurements and an analysis that accounts for their pairing. The registry record does not report whether repeated primary outcome measurements were analyzed or provide a numerical estimate of any change.

A treatment effect is usually a contrast between outcomes under different treatment conditions. Here, the record describes one implementation arm and no separate control group. There is therefore no randomized or concurrent control comparison in the listed design. Other rehabilitation services were also part of participants’ plans of care. A single-group outcome cannot isolate the contribution of the 3-Step Workout for Life program from the rest of care or from changes that could occur over time. This is a design limitation, not a calculation that can be repaired by re-expressing the reported endpoint.

What do the mean and standard deviation describe?

The primary endpoint is specified as a mean of a continuous measure with standard deviation. In general, the mean describes the center of the observed values, while the standard deviation describes their spread around that center. They answer different questions: the first concerns the average score, and the second concerns how much scores vary among the people measured. Neither statistic alone communicates the precision of the estimated mean. A standard error or confidence interval may be used for that purpose, depending on the analysis and assumptions.

The self-care ratio has a stated range from 0.17 to 1. A mean should therefore be interpreted within that scale and in relation to its definition: higher scores correspond to greater self-care ability. General statistical caution is warranted when interpreting bounded measures, because the possible values are restricted and distributions may not be symmetric. The registry record does not provide the observed distribution, numerical mean, standard deviation, or a description of any distributional checks. It is not possible to assess from the record whether a particular modeling assumption was appropriate.

Why does the absence of a comparison matter?

For a randomized comparison, treatment groups are intended to be comparable on average, allowing a difference in outcomes to be interpreted as a treatment contrast subject to uncertainty and study limitations. This record lists allocation as NA and a single-group model. A comparison with a hypothetical control group would require assumptions or external data that are not reported in the registry record. No such comparison should be inferred from the primary endpoint’s mean or from the implementation aim.

General explanations of uncertainty do not substitute for a reported analysis. A confidence interval would describe uncertainty around a specified estimate under an analysis model; a p-value would quantify how surprising data would be under a specified null hypothesis and statistical assumptions. Neither can be reconstructed without the relevant results and analysis details. The registry does not report the primary endpoint estimate, inferential test, confidence interval, or statistical analysis plan.

How should sample-size planning be read?

The sample-size assumptions describe a planning illustration, not the study’s own design justification. The stated illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with an effect to detect expressed as a fraction of the observed effect. For non-time-to-event outcomes, the stated planning quantity is participants per arm. These assumptions describe a hypothetical two-arm calculation; they do not change the actual single-group design recorded for this study.

Any sample-size values based on that illustration are planning scenarios, not observed study results and not observed power. They should not be interpreted as evidence that the study had a particular probability of detecting an effect. The registry record does not report a protocol-based sample-size justification or a planned effect size for the actual single-group implementation study. It also does not report a randomized two-arm design. No planning scenario can establish what the study’s outcomes were or how precisely they were estimated.

What can be said about recalculation?

A recalculation from summary statistics is possible only when those statistics and the relevant analysis contrast are available. The primary outcome’s numerical summary is not reported in the registry record, and there is no control group for an unadjusted between-group calculation. No recalculated effect or inferential result can therefore be described. The registry record does not identify a sponsor analysis that could be compared with a recalculation.

More broadly, statistical interpretation depends on the estimand, timing, analysis population, handling of incomplete measurements, and model. Those details are not reported in the registry record. General statistical concepts can explain what different methods would mean, but cannot fill in an unreported analysis plan or produce a result from an endpoint definition alone.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Implementation Arm")
n   <- c(9)
m   <- c(0.93)
sp  <- c(0.14)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Implementation Arm  9  0.930  0.140  0.822  1.038

11. Multiplicity, Missing Data and Analysis Populations

The record identifies one primary outcome, the OASIS self-care ratio, and lists secondary outcomes for OASIS mobility, EuroQoL, and the Activity Measure of Post-Acute Care-Home Health Version. It reports four outcome measures and four analyses. The mapping between each measure and each analysis is not reported in the registry record. Nor does the record report whether the secondary outcomes were analyzed at the same time point or with the same approach as the primary endpoint.

When multiple outcomes are tested, general statistical practice considers the possibility of chance findings across the set of tests. Methods to address multiplicity depend on which hypotheses were prespecified and what conclusions the analysis is intended to support. A multiplicity adjustment or a prespecified hierarchy is not reported in the registry record. Because numerical results are also not reported, no conclusion about the impact of multiplicity can be drawn.

Missing-data procedures are not reported in the registry record. The enrollment count does not establish the number of participants with a discharge assessment or complete data for every outcome. The record does not describe reasons for missing measurements, imputation, or sensitivity analyses. The analysis population and any exclusions are also not reported in the registry record. These omissions limit interpretation of how the reported enrollment would relate to any outcome estimate, even if such an estimate were present.

The record’s status is terminated, but it does not explain why the study ended or whether termination affected outcome collection. Those details should not be inferred from the status alone.

12. 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.

Most frequent non-serious adverse event terms

The registry reports 0 serious adverse events among 10 participants at risk, 6 participants with other adverse events among 10 at risk, and 0 deaths. No serious adverse-event terms are listed in the registry record. These are counts for the implementation arm; they are not comparisons between treatment groups.

Serious adverse events and other adverse events are separate reporting categories. A count in the other-adverse-event category does not mean that the same number of events occurred: the record reports participants affected, not a detailed event tally or event descriptions. The registry does not report the kinds of other events, their timing, severity, duration, or whether investigators considered them related to the program. The period over which participants were monitored for adverse events is not reported in the registry record.

Zero reported serious events and zero deaths describe the recorded counts in this group; they do not establish that risk is absent. With no control group, these figures cannot quantify a comparative safety effect. The enrollment was 10, and the safety counts do not provide a substitute for the missing clinical outcome results or a complete account of adverse-event monitoring.

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

The record establishes that the study was designed as a single-group implementation project for the 3-Step Workout for Life program in a home health agency. It states an aim to adapt delivery through learning cycles and evaluate implementation-related clinical and patient outcomes. It also defines a primary measure of self-care ability at discharge and names mobility, quality of life, and home health activity measures as secondary outcomes.

It does not report numerical results for the primary outcome or the named secondary outcomes. There is no reported mean, standard deviation, estimate of change, or uncertainty interval for self-care. As a result, the record does not show the level of self-care ability observed at discharge or how variable participant scores were. It also does not establish whether scores improved, declined, or stayed similar over time.

The single-group design cannot separate outcomes associated with the program from outcomes associated with other rehabilitation services or changes over time. Since allocation is NA and there is no described control arm, the record does not support a causal comparison. The project’s implementation focus is important context: it was intended to study adaptation and delivery, not described as a randomized efficacy comparison.

Enrollment was 10, and the study status is terminated. The reason for termination and the completeness of outcome collection are not reported in the registry record. The adverse-event counts are descriptive and do not establish comparative safety. Together, the available information supports describing the intended study and its recorded safety counts, but not judging the size, direction, or precision of a clinical outcome effect.

These limits do not mean that the program did or did not produce a particular result. They mean that the registry record does not report the information needed to estimate or interpret such a result. Any claim about effectiveness, lack of effectiveness, or comparative safety would go beyond the outcomes and design details reported.

14. Why This Trial Matters Statistically

This study raises a statistical question that differs from the question asked by a conventional controlled trial. Its stated purpose is to adapt and implement a program in a local home health agency, including using learning cycles to adjust treatment dose and delivery mode. That makes implementation processes and the clarity of outcome measurement central to interpretation, alongside clinical and patient outcomes.

The primary endpoint is a bounded ratio that translates OASIS self-care activity scores into an indication of independence. Its direction is clear: higher scores indicate greater self-care ability. Reporting a well-defined measure and timeframe helps readers understand what an outcome is intended to capture. But useful interpretation also requires the observed values, their variability, the number assessed, and an account of missing measurements. Those numerical outcome results and analysis details are not reported in the registry record.

The design also illustrates why implementation evidence and comparative treatment evidence should not be conflated. A single-group project can describe delivery and outcomes in its participants, but it cannot provide a randomized contrast against a separate control group. Other rehabilitation services were part of the care plan, which further defines the context in which outcomes would be observed. These features matter when deciding what claims the design could support.

Finally, the registry record’s terminated status and small enrollment call for careful attention to completeness and precision, but the reason for termination and numerical clinical results are not reported. Clear reporting of outcome estimates, uncertainty, implementation measures, and analysis populations would be needed to assess what the project learned. Without those results, the record is informative about aims and design, while leaving the clinical outcomes unresolved.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations specific to this record constrain statistical interpretation. First, enrollment was 10, and the study used a single-group design. There is no separate control arm and no randomized allocation described. Outcomes therefore cannot be interpreted as a controlled treatment effect. Participants also received other rehabilitation services based on their plan of care, so the program was not the only care described in the implementation arm.

Second, the numerical primary outcome and secondary outcome results are not reported in the registry record. The record does not give estimates, measures of variability, confidence intervals, or outcome-specific analysis populations. It is therefore not possible to evaluate the size or precision of the clinical outcomes. Although the primary timeframe is described as discharge, on average 2 months, participant-specific follow-up timing is not reported.

Third, the status is terminated, but the reason for termination and its implications for recruitment, implementation, and data collection are not reported in the registry record. The record does not describe how many participants completed assessments, why any outcomes might be missing, or how missing data were handled. Implementation details such as fidelity, dose actually received, and variation across learning cycles are also not reported.

Masking is listed as none. The record does not explain whether outcome assessors were independent or how potential measurement bias was addressed. The statistical analysis plan, multiplicity approach, and mapping between the four outcome measures and four analyses are not reported. Participant characteristics beyond the listed conditions are not reported in the registry record, which limits assessment of how well the enrolled group represents other home health populations. These limitations leave the study’s numerical clinical findings and their generalizability uncertain.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Implementing 3-Step Workout for Life in Home Health — NCT04709783.
• Registry record last updated 2025-01-03; status last verified 2024-11.
• Results first posted 2025-01-03.
• 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.

19. Record Summary

The registry record describes NCT04709783, “Implementing 3-Step Workout for Life in Home Health,” sponsored by the University of Florida. The project aimed to adapt and implement the 3-Step Workout for Life program in a local home health agency, using learning cycles to adjust dose and delivery mode. Enrollment is 10; the design is single-group, allocation is NA, and masking is none. The status is terminated.

The primary outcome is the OASIS self-care ratio at discharge, on average 2 months. Secondary outcomes include OASIS mobility, EuroQoL, and the Activity Measure of Post-Acute Care-Home Health Version. Numerical clinical outcome results, the reason for termination, and details of missing-data handling are not reported in the registry record. Safety counts include 0 serious adverse events, 6 participants with other adverse events, and 0 deaths among 10 at risk.