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 Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth (NCT05029284), a na na study. The primary outcome is Incidence of Treatment-Emergent Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05029284 |
| Phase | NA |
| Condition | Stroke, Stroke, Ischemic, Stroke Hemorrhagic |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Minnesota |
| Results posted | Yes |
2. Clinical Question
Population
Adults with stroke-related disability, with the intervention intended for people within the first 12 months after stroke. The conditions listed include stroke, ischemic stroke, and hemorrhagic stroke.
Intervention
teleABLE, a behavioral activation-based intervention delivered by videoconferencing. Participants were to complete 12 sessions guided by an intervention therapist and participant workbook.
Comparator
There is no separate comparison group. The record identifies a single-group model and no allocation to a control condition, so it does not support a between-group treatment comparison.
Primary question
The study’s stated purpose is to assess whether teleABLE is feasible and acceptable to adults within the first 12 months post-stroke. The registered primary outcome is narrower: a count of treatment-related serious and non-serious adverse events during intervention delivery, from week 2 through week 7.
These are related but distinct questions. Adverse-event counts describe safety events recorded over the specified period; they do not, by themselves, quantify whether participants could complete the sessions or found the intervention acceptable. The brief summary describes assessments and activity monitoring at baseline and post-intervention, with sedentary behavior among the study’s interests. The registry record does not report quantified feasibility or acceptability results, or numerical results for the listed changes in participation restrictions, health-related quality of life, and sedentary minutes. The available record therefore describes the study’s aims and its registered safety outcome more fully than it answers the broader feasibility question.
3. Trial Design
This is a completed, single-group behavioral study of teleABLE, delivered by videoconferencing. The registry identifies allocation as not applicable and masking as none. There is no randomized or concurrent control group, so the study is not designed to estimate a treatment contrast between teleABLE and another intervention or usual care.
The intervention description says participants complete 12 teleABLE sessions, guided by an intervention therapist and participant workbook. The brief summary describes assessments and activity monitoring at baseline and at 8 weeks after baseline, using an activPAL micro3, and frames the intended population as adults within the first 12 months post-stroke. These are descriptions of the planned study procedures; they do not establish how many participants completed each procedure.
The registry enrollment field gives 11, while the brief summary says 10 participants will complete assessments and activity monitoring. Those figures refer to different record statements, and the registry record does not reconcile them or report completion counts. The enrollment entry should not be treated as evidence that every enrolled participant completed the intervention or contributed data to every outcome.
The registry lists five outcome measures, including the primary adverse-event outcome and secondary outcomes concerning participation restrictions, health-related quality of life, and sedentary minutes. It lists no analysis entries. The record does not report a statistical analysis plan, a sample-size justification, an interim-analysis plan, or detailed procedures for handling repeated measurements. The study’s single-group, formative design is important when interpreting any observed change: without a control group, changes over time cannot be separated from other explanations using a randomized comparison.
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 | teleABLE |
|---|---|
| STARTED | 11 |
| COMPLETED | 10 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | teleABLE |
|---|---|
| Lost to Follow-up | 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 | teleABLE |
|---|---|---|
| Participants analysed | 11 | |
| Age, Continuous | years | 53 (40 to 73) |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 8 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Incidence of Treatment-Emergent Adverse Events, measured over week 2 through week 7.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | adverse events |
| Endpoint classification | not reduced to a single comparison |
The registered primary endpoint is the number of treatment-related serious and non-serious adverse events occurring during intervention delivery. The timeframe is week 2 through week 7. The description gives examples of serious events, such as an injurious event, and non-serious events, such as a fall without injury. The endpoint is recorded as a count, rather than as a comparison of outcomes between treatment groups.
Counting events can describe what occurred during the intervention period and can help characterize the safety experience recorded in a formative study. Serious and non-serious events are distinguished because their clinical consequences differ; combining them into a single undifferentiated category could obscure that distinction. The registry reports zero serious events and two other, non-serious events for the teleABLE group. It also reports 10 at risk for each of those event categories.
These counts should be read as event data, not automatically as counts of participants who experienced an event. The record does not provide event-level descriptions for the non-serious events or explain whether any participant could contribute more than one event. It also does not give a comparison group or an estimated background event rate. Consequently, the endpoint describes recorded events within the study; it does not establish whether teleABLE changed event risk relative to another condition.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary safety results record zero serious adverse events and two other adverse events in the teleABLE group. The registry lists 10 at risk for serious events and 10 at risk for other events. The outcome is a count of events, so those figures should not be read as evidence that a particular number of participants experienced an event. The record does not provide event narratives, participant-level data, or a breakdown of event timing beyond the specified overall timeframe.
The safety findings are descriptive. This was a single-group study, with no control group against which to compare event counts. Without a comparison, the posted counts cannot show whether events were more or less frequent than they would have been without the intervention, or under another intervention. The record also does not provide an inferential estimate, such as a confidence interval, for the event count or for a treatment contrast. The counts therefore convey what was registered for this group, but not the precision of a comparative safety effect.
The study’s broader purpose was to assess feasibility and acceptability. Those constructs are not answered by the adverse-event count alone. The brief summary describes assessments, activity monitoring, and intended session delivery, but the registry record does not report numerical completion, adherence, acceptability, or feasibility results. Nor does it give numerical results for the listed secondary changes in participation restrictions, health-related quality of life, or sedentary minutes. No direction or magnitude of change for those outcomes can be inferred from their names.
The registry enrollment field is 11, while the brief summary refers to 10 participants completing assessments and activity monitoring. The record does not clarify how those statements relate to each other or give outcome-specific denominators. It is therefore important not to treat the enrollment figure as the analyzed sample for every outcome. The record lists no analysis entries, and it does not present estimates or statistical tests for the study outcomes.
Overall, the posted results support a limited description of recorded adverse events during the stated intervention period. They do not establish a comparative treatment effect, provide a precise estimate of event risk, or resolve the study’s broader feasibility and acceptability questions. Any interpretation should remain within those boundaries.
9. Statistical Methods Explained
The design determines which statistical conclusions are available. This study is listed as single-group, with allocation not applicable and no masking. A single-group study can describe observations collected from participants who receive an intervention, but it does not create a concurrent comparison for separating intervention effects from other influences. Changes from baseline to post-intervention, if reported, would be within-participant observations; without a control group, they would not by themselves identify what would have happened over the same period without teleABLE.
What does a count endpoint represent?
The primary outcome is a number of treatment-related serious and non-serious adverse events over a stated timeframe. In general, a count outcome records how many events occur, rather than measuring a continuous quantity such as minutes or a rating scale. Counts can be affected by the amount of observation time and by whether multiple events can occur for one participant. The registry describes the event categories and timeframe, but does not report participant-level event histories or clarify whether repeat events occurred. The event counts should therefore be presented as counts, not converted into participant risks or rates without the required information.
In general, count data may show over-dispersion when their variability exceeds what a simple count model assumes. Methods for count outcomes can account for this when the data and analysis plan warrant it. However, the registry record does not report a statistical model or any count-data analysis. It would be inappropriate to imply that a particular model, adjustment, or dispersion assumption was used.
What can a confidence interval tell the reader?
In general, a confidence interval describes the uncertainty around an estimated quantity under the assumptions of the analysis. For a comparative study, an interval around a treatment contrast can convey both the estimated direction and the range of values compatible with the data and method. An interval around a count or rate can instead describe uncertainty about that count-based quantity. The registry record does not report confidence intervals or a comparative estimate for the primary outcome. The event counts alone do not show how precisely an underlying event frequency has been estimated.
A p-value, in general, assesses how compatible data are with a specified null hypothesis under a statistical model. It is not a measure of clinical importance and does not replace an estimate with its uncertainty. No p-values or hypothesis tests are listed in the registry record. Since there is no control group, the record also does not define a between-group treatment contrast for which a conventional comparative test could be interpreted.
How should planning calculations be understood?
Planning illustrations based on an observed effect are not observed power and do not demonstrate that this study was adequately powered. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is a stated fraction of the observed effect. The instructions distinguish total event counts for time-to-event calculations from participants per arm for other calculations. These are planning conventions for a hypothetical two-arm design, whereas this registry record describes a single-group study. Such illustrations do not describe the trial’s actual allocation, and the registry does not report a sample-size justification for the formative study.
The distinction between planning and analysis is general: planning calculations address what a future design might require under chosen assumptions, while analysis uses observed data to estimate outcomes and uncertainty. A planning illustration does not add participants to the study, create a comparison group, or establish that an effect was detected. Its assumptions should not be mistaken for the study’s own statistical plan, which is not reported in the registry record.
What analysis details are missing?
The registry lists no analysis entries. The statistical model, treatment of repeated assessments, handling of missing observations, analysis population, and approach to multiplicity are not reported in the registry record. These details matter because they determine how measurements are combined, which participants contribute to each estimate, and how uncertainty is quantified. Without them, the outcomes can be described only to the extent that numerical results are posted; analyses should not be reverse-engineered from study aims or outcome names.
In general, a clear report of estimates, denominators, and uncertainty helps readers distinguish an observed value from a stable or precise estimate. In this record, the safety counts are available, but inferential analyses and detailed outcome results are not. The most defensible statistical reading is therefore descriptive and limited to those posted counts.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures and names secondary outcomes involving participation restrictions, health-related quality of life, and sedentary minutes. It does not report a multiplicity strategy, such as a prespecified hierarchy of outcomes or an adjustment for testing several outcomes. The registry record also lists no analysis entries. Without an analysis plan and outcome-level results, it is not possible to determine how multiple outcomes or repeated assessments were handled. General statistical practice recognizes that examining many outcomes can increase the chance of apparently notable findings by chance, but the registry record does not establish that such testing occurred.
Missing-data procedures are not reported in the registry record. The record does not give outcome-specific denominators, missingness counts, reasons for missing observations, or methods for handling incomplete follow-up. The enrollment field is 11, while the brief summary describes 10 participants completing assessments and activity monitoring; the record does not reconcile these statements. Neither figure establishes the denominator used for every analysis.
The analysis population is also not reported in the registry record. It is not stated whether analyses were intended to include all enrolled participants, those who began the intervention, those who completed sessions, or participants with available outcome data. These distinctions can affect how results are interpreted, especially in a feasibility study where completion and engagement are relevant outcomes. No assumptions about missing observations or participant inclusion should be attributed to the study without a reported analysis plan.
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 |
|---|---|---|---|
| teleABLE | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| teleABLE | 0 of 10 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| teleABLE | 2 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | teleABLE |
|---|---|---|
| Muscle soreness | Musculoskeletal and connective tissue disorders | 1 of 10 |
| Skin irritation | Skin and subcutaneous tissue disorders | 1 of 10 |
The registry records zero serious adverse events for the teleABLE group and two other, non-serious adverse events. It reports 10 at risk for serious events and 10 at risk for other events. The endpoint description concerns treatment-related events during intervention delivery from week 2 through week 7; it gives an injurious event and a fall without injury as examples of serious and non-serious events, respectively.
These are event counts, not necessarily numbers of participants affected. The record does not provide event narratives or state whether the other events occurred in one participant or more than one. It lists no serious-event terms and records zero deaths. The absence of a listed serious event in this group is a descriptive observation, not proof that serious events are impossible or that a different intervention would have a different safety profile.
Because the study has no comparison group and the registry provides no inferential estimate, the counts do not support a comparative claim about safety. The record also does not report a rate adjusted for observation time or additional context about event ascertainment. Interpret the figures as the events recorded for this study and timeframe, without extending them beyond that setting.
12. What the Result Does, and Does Not, Mean
The record describes a completed formative study of a telehealth behavioral intervention for adults after stroke. Its stated purpose is to assess feasibility and acceptability, and its registered primary endpoint counts treatment-related serious and non-serious adverse events during intervention delivery. The posted safety figures are zero serious events and two other events for the teleABLE group, with 10 at risk listed for each category.
Those results can be read as descriptive safety information for the group and timeframe recorded. They do not show a comparative effect because there is no control group. They also do not establish a precise event rate: the record gives event counts but does not report uncertainty estimates, participant-level event details, or a rate analysis. The figures should not be interpreted as evidence that the intervention caused or prevented events.
The study’s feasibility and acceptability aims remain broader than its posted primary safety result. The brief summary describes session delivery, assessments, and activity monitoring, but the registry record does not report numerical results for feasibility, acceptability, or completion. Although changes in participation restrictions, health-related quality of life, and sedentary minutes are listed as secondary outcomes, their numerical results are not reported in the registry record.
The record also does not establish that all enrolled participants contributed to each outcome. The enrollment field and the brief summary’s intended assessment count are not reconciled, and outcome-specific denominators are not reported. There are no analysis entries or reported inferential results. The appropriate conclusion is limited: the registry records the specified event counts for this single group, while comparative effects and broader feasibility findings are not established by the posted results.
13. Why This Trial Matters Statistically
This study illustrates why the design and the question must be read together. A single-group formative study can document whether an intervention was delivered and can describe outcomes observed during that experience. It cannot, without a comparison condition, distinguish intervention-related changes from changes that might have occurred over time for other reasons. This distinction is especially important when a study’s stated purpose is feasibility and acceptability but its registered primary endpoint is an adverse-event count.
It also highlights the difference between an event count and a participant-level risk estimate. The registry reports counts of serious and other events, along with the number at risk for each category. Those data are useful descriptive information, but the record does not provide event histories, rates, confidence intervals, or a comparator. Readers should avoid treating sparse descriptive safety data as a precise estimate of risk.
Outcome names alone do not supply results. Participation restrictions, health-related quality of life, and sedentary minutes are listed as secondary outcomes, but the registry record does not report their numerical findings or analysis details. Likewise, a statement that participants were intended to complete sessions and assessments is not evidence of the observed completion or acceptability of those activities.
Finally, planning calculations and trial analyses answer different questions. The stated sample-size illustration uses two-arm planning assumptions, while the study itself is single-group. Recognizing that mismatch helps prevent a planning scenario from being mistaken for the design or evidence of the formative study. Clear reporting of denominators, missing data, outcome estimates, and uncertainty would be needed to support stronger statistical conclusions.
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 principal limitation for interpretation is the single-group design. With no control condition, the study cannot estimate a randomized between-group contrast, and any change over time would not by itself identify an intervention effect. The registry record does not report inferential estimates or uncertainty intervals for the posted safety outcome.
The reported primary outcome is a count of events. The registry does not provide event-level descriptions for the non-serious events, clarify whether repeat events occurred, or report rates adjusted for observation time. It also does not describe how treatment-relatedness was assessed. These omissions limit the detail with which the safety findings can be interpreted.
There is a difference between the enrollment field, which lists 11, and the brief summary, which describes 10 participants completing assessments and activity monitoring. The registry record does not reconcile those statements or provide outcome-specific denominators. It is therefore unclear from the record how many observations contributed to each outcome.
Although feasibility and acceptability are central to the study’s stated purpose, numerical results for these constructs are not reported in the registry record. Numerical results for the listed secondary outcomes are also not reported. The record lists no analysis entries and does not report the analysis population, missing-data procedures, multiplicity strategy, or detailed statistical methods. These limitations preclude conclusions about changes in sedentary behavior or other secondary outcomes from the posted information alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Behavioral Activation for Post-Stroke Sedentary Behavior Using Telehealth — NCT05029284.
- Registry record last updated 2025-06-29; status last verified 2025-06.
- Results first posted 2025-06-29.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, single-group study of teleABLE, a behavioral intervention delivered by videoconferencing to adults after stroke. Participants were to complete 12 sessions with therapist guidance and a workbook. The stated study purpose is to assess feasibility and acceptability within the first 12 months post-stroke.
The registered primary endpoint is the count of treatment-related serious and non-serious adverse events during intervention delivery, from week 2 through week 7. The teleABLE group has zero serious events and two other events recorded, with 10 at risk listed for each category. The enrollment field gives 11; the brief summary describes 10 participants completing assessments and activity monitoring, and the record does not reconcile the figures.
The record lists secondary outcomes concerning participation restrictions, health-related quality of life, and sedentary minutes, but does not report their numerical results. It lists no analysis entries or inferential results. Because the design is single-group, the posted event counts are descriptive and do not provide a comparative treatment effect.