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 The Effects of DVD Education on Physical Activity and Self Management of Heart Failure (NCT01622010), a randomized na study. The primary outcome is Frequency of Exercise - General.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01622010 |
| Phase | NA |
| Condition | Heart Failure |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Manitoba |
| Results posted | Yes |
2. Clinical Question
Population
People with heart failure were the population of interest. The registry record lists an enrollment of 30. It does not report further eligibility details or a fuller description of the participants, so characteristics such as age, disease severity, and prior activity levels cannot be assessed.
Intervention
The intervention was standard care with video enhancement. Participants were invited to attend an Allied Health Education Class and could be referred to physiotherapy from the Heart Failure Clinic at a physician’s request under the clinic’s standard protocol. The arm description adds a copy of the DVD, “Keeping the Beat with Physiotherapy: Heart Failure edition.”
Comparator
The comparator was standard care: an invitation to attend an Allied Health Education Class, with possible referral to physiotherapy from the Heart Failure Clinic at a physician’s request under the standard clinic protocol. The registry record does not report that the education-class invitation was attendance or that referral occurred for every participant.
Primary question
The primary question concerned frequency of exercise in general at 3 months, assessed using telephone survey responses on a ranked Likert scale from 1 to 4, where 1 represented the better outcome. The investigators’ stated aim was to compare behaviour change in heart-failure self-management after reinforced multimedia education focused on physical activity with standard care alone. The registry record does not report a primary-outcome comparison or a result.
3. Trial Design
The registry record describes a randomized, single-masked, parallel trial of people with heart failure. Enrollment was 30. The study start is listed as 2013-04, and primary completion as 2014-07. Its status is terminated. The registry record does not explain why the trial was terminated, whether enrollment or follow-up ended as planned, or how many participants completed each assessment.
The comparison was standard care with video enhancement versus standard care. Both arm descriptions include an invitation to an Allied Health Education Class and the possibility of physiotherapy referral from the Heart Failure Clinic at a physician’s request under the clinic’s standard protocol. The video-enhancement arm additionally received a copy of “Keeping the Beat with Physiotherapy: Heart Failure edition.” The record also lists an Allied Health Education Class option, physiotherapy treatment intervention on referral, and the DVD intervention.
Randomized allocation means that assignment was intended to use a chance-based process; general statistical interpretation does not establish how that process was implemented. The sequence-generation method, allocation concealment, and any restrictions on randomization are not reported in the registry record. “Single” masking is recorded, but the record does not identify which people were masked or how masking was maintained. The parallel model indicates that the arms were compared as separate groups rather than as a crossover sequence.
The study is listed as phase NA. Its listed secondary outcomes include readmission rate and confidence in activity-related decisions and decisions regarding weight changes. Four outcome measures and three analyses are recorded, but the registry record does not supply enough detail to reconstruct their definitions, timing, or analysis plan. The trial status alone does not establish whether every planned assessment was completed or why the study ended.
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 | Standard Care With Video Enhancement | Standard Care |
|---|---|---|
| STARTED | 18 | 12 |
| COMPLETED | 12 | 8 |
| NOT COMPLETED | 6 | 4 |
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 | Standard Care With Video Enhancement | Standard Care | Total |
|---|---|---|---|---|
| Participants analysed | 18 | 12 | 30 | |
| Age, Continuous | Years | 62.7 (SD 16.2) | 65.7 (SD 7.0) | 63.9 (SD 13.2) |
| Sex: Female, Male: Female | Participants | 3 | 0 | 3 |
| Sex: Female, Male: Male | Participants | 15 | 12 | 27 |
| Region of Enrollment: Canada | participants | 18 | 12 | 30 |
| New York Heart Association (NYHA) Classification: NYHA class I | participants | 4 | 4 | 8 |
| New York Heart Association (NYHA) Classification: NYHA class II | participants | 4 | 4 | 8 |
| New York Heart Association (NYHA) Classification: NYHA class III | participants | 9 | 3 | 12 |
| New York Heart Association (NYHA) Classification: NYHA class IV | participants | 0 | 0 | 0 |
| New York Heart Association (NYHA) Classification: Unclassified | participants | 1 | 1 | 2 |
| Working Status: Retired | participants | 6 | 3 | 9 |
| Working Status: Disability | participants | 1 | 0 | 1 |
| Working Status: Working | participants | 5 | 2 | 7 |
| Working Status: Unknown | participants | 6 | 7 | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Frequency of Exercise - General, measured over 3 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled “Frequency of Exercise - General.” It is described as a number of participants, based on telephone survey responses at 3 months. Responses use a ranked Likert scale from 1 to 4, with 1 representing the better outcome. Thus, the endpoint concerns participants’ reported exercise frequency rather than an objective activity measurement, as far as the registry description states.
A self-report measure can capture a participant’s account of activity that may not be represented in a clinical record. A ranked response scale also allows ordered categories to describe differences in reported frequency. General statistical interpretation: the ordering of categories is meaningful, but the distances between adjacent categories are not necessarily equal. Analyses need to respect the scale’s structure and the outcome definition.
The registry record does not provide the wording of the survey question, the meaning of each response category, the scoring procedure beyond the direction of the better outcome, or how responses were handled when unavailable. It also does not report an arm-level result or an estimated treatment contrast for this outcome. The record states that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, no effect estimate or measure of its precision for a single primary comparison can be interpreted from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question and design, but it does not report a primary-outcome comparison. It therefore does not show whether exercise-frequency responses differed between standard care with video enhancement and standard care, nor how large or precise any difference might have been. The investigators’ expectation that the added education would improve self-management is an anticipated benefit described in the study summary, not a reported finding.
The primary outcome was assessed by telephone survey at 3 months and used a ranked scale from 1 to 4, with 1 designated as the better outcome. The record notes that the outcome has several categories or time points and was not reduced to a single comparison. Without arm-specific response distributions, an analysis definition, and a reported contrast, the scale’s direction alone cannot establish the direction or size of an observed effect. No p-value, confidence interval, or other primary effect estimate is reported in the registry record.
Four outcome measures and three analyses are recorded. The secondary outcomes include readmission rate and two measures of confidence in decision making. These registry entries indicate the range of outcomes under consideration; they do not establish that results were collected or analyzed for each outcome. The registry record does not report comparative results for these outcomes, so neither benefit nor lack of benefit can be inferred from their listing.
Enrollment was 30, and the record gives counts at risk for serious and other adverse events by arm. These safety counts should be read as registry entries for the listed groups, not as evidence about unrecorded outcomes or about the comparative effect of the education. The record lists no affected participants for the specified event categories, but the death fields are not reported. The available safety entries do not replace a report of follow-up completeness or a full adverse-event analysis.
The study status is terminated, but the reason is not reported in the registry record. Termination does not by itself identify a problem with the intervention, the conduct of the study, or the results. Because the primary comparison, participant flow, analysis population, and missing-data handling are not reported, the posted information supports a description of the trial, not a conclusion about the effect of the DVD education.
9. Statistical Methods Explained
The record identifies a randomized parallel design with single masking. General statistical interpretation: random allocation is intended to make the assigned groups comparable on average with respect to both measured and unmeasured characteristics. That intention depends on how allocation was generated and implemented. The registry record does not report the randomization sequence, allocation concealment, or any procedures used to preserve the assigned groups in analysis. The label “single” does not identify who was masked. These omissions limit assessment of the safeguards against selection and measurement bias; they do not establish that such bias occurred.
What does the outcome scale represent?
The primary endpoint is based on telephone survey responses on a ranked Likert scale from 1 to 4, with 1 representing the better outcome. General statistical interpretation: ordered categories provide rank information, but a one-category change need not represent the same amount of change across the scale. A method treating the values as ordinary numeric measurements would rely on assumptions about the spacing of categories. A method based on category frequencies or ranks would make different assumptions. The registry record does not specify the analysis method or explain how the categories and time points were handled.
The outcome title refers to exercise frequency in general, and the measure is recorded as a number of participants. The record does not state the survey wording, how the categories map to frequency, whether the analysis used a participant-level summary or category counts, or how repeated time points were incorporated. It explicitly states that the primary outcome has several categories or time points and was not reduced to one comparison. A single summary effect cannot be reconstructed from that description alone.
How should an effect estimate be interpreted?
General statistical interpretation: an effect estimate describes the contrast between groups under a stated outcome definition and analysis. A confidence interval describes the range of values compatible with the data and the specified statistical model, subject to that model’s assumptions. Greater precision corresponds to a narrower interval; an interval is not a guarantee that the true effect lies within its endpoints. The registry record does not report a primary effect estimate, confidence interval, or p-value. It is therefore not possible to discuss the magnitude, direction, or precision of the primary comparison.
The record lists four outcome measures and three analyses. Those counts do not identify which outcome or analysis was primary in the statistical analysis, whether all recorded analyses were completed, or how any analysis was chosen. No adjustment for multiple comparisons is reported. General statistical interpretation: when several outcomes or analyses are examined, the chance of at least one apparently unusual result can increase if each is interpreted separately without accounting for that multiplicity. The record does not permit a judgment about whether this concern was addressed.
What do the enrollment and planning details establish?
Enrollment was 30. The registry record includes general planning assumptions for an illustration based on an observed effect: a two-sided significance level of 0.05, equal allocation, a normal approximation, and detection of a stated fraction of the observed effect. It also specifies that time-to-event illustrations use total events, while other illustrations use participants per arm. These are planning assumptions, not evidence that the trial was designed or analyzed using those assumptions. The registry record does not report its own sample-size justification, target effect, or planning procedure. No planning result is reported in the trial details, and an illustrative sample size should not be read as observed power.
General statistical interpretation: sample-size planning describes the amount of information a proposed design is expected to yield under specified assumptions. It does not determine the observed effect, and post hoc power does not substitute for an effect estimate with its uncertainty. Here, the missing primary comparison means there is no reported observed effect from which to assess precision. The planning assumptions cannot fill that gap or show whether enrollment was adequate for the intended question.
Why do event counts need context?
The registry lists participants at risk and participants affected for serious and other adverse-event categories by arm. Such counts are descriptive. Their interpretation depends on the definitions of the events, the observation period, the completeness of follow-up, and how events were collected. Those details are not reported in the registry record. General statistical interpretation: sparse event counts can provide limited information about differences between groups, and a recorded zero does not establish that an event is impossible or that no event occurred outside the recorded observation. The listed counts do not provide a comparative safety estimate or a confidence interval.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists four outcome measures and three analyses, but it does not describe a multiplicity strategy. It does not identify which comparisons were prespecified, whether the secondary outcomes were confirmatory or exploratory, or whether any adjustment was planned. General statistical interpretation: when multiple outcomes or analyses are considered, interpreting each result as if it were the only test can overstate the evidence from an unusual result. Without the analysis plan and reported results, the extent of this issue cannot be assessed.
Missing-data methods are not reported in the registry record. The record does not give the number of participants with primary-outcome data, explain how incomplete telephone surveys were handled, or state whether any imputation or sensitivity analysis was used. It also does not report participant flow through follow-up. These details matter because an analysis based only on participants with observed responses can be affected if missingness is related to outcome or treatment assignment. That is a general methodological concern, not a claim that missing data occurred in this trial.
The analysis populations are not reported in the registry record. It is not possible to determine whether the primary analysis followed randomized assignment, included only participants who received the intervention, or used another population. The record also does not describe interim analyses or stopping rules. The terminated status does not establish whether interim analyses occurred or why the trial ended. As a result, the available record does not support a complete assessment of multiplicity, missingness, or analysis-population choices.
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 |
|---|---|---|---|
| Standard Care With Video Enhancement | 0 | 18 | 0.0% |
| Standard Care | 0 | 12 | 0.0% |
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 |
|---|---|
| Standard Care With Video Enhancement | 0 of 18 |
| Standard Care | 0 of 12 |
For serious adverse events, the registry lists 0 affected participants among 18 at risk in the standard-care-with-video-enhancement group and 0 among 12 at risk in the standard-care group. For other adverse events, it also lists 0 affected participants among 18 at risk and 0 among 12 at risk, respectively. No top serious-event terms are listed. The death fields are not reported in the registry record.
These entries describe the counts recorded for the listed groups; they do not establish that all events were captured or that every participant had complete safety follow-up. The registry record does not report event definitions, collection procedures, observation duration, or a comparative safety analysis. General statistical interpretation: a zero count is not proof that the underlying event risk is zero, and small event counts provide limited precision for comparing groups. The entries should therefore be read as descriptive registry counts, not as a definitive estimate of safety or a substitute for the missing primary-outcome results.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, single-masked, parallel trial was conducted to examine standard heart-failure care with video-enhanced education compared with standard care. It identifies an exercise-frequency outcome assessed by telephone survey at 3 months and lists additional outcomes concerning readmission and confidence in decision making. Enrollment was 30, and the study status is terminated.
What the posted results do not establish is whether exercise-frequency responses differed between groups. No primary-outcome effect estimate, confidence interval, or p-value is reported. The registry notes that the primary outcome involved several categories or time points and was not reduced to one comparison. The stated expectation of improved self-management and fewer hospital admissions is the investigators’ rationale, not evidence of an observed effect. The listed secondary outcomes also have no reported comparative results in the record.
General statistical interpretation: an absent or incomplete result is not equivalent to a finding of no difference. Without a defined contrast and its estimate, the data cannot show either the direction or the size of a difference, and its precision cannot be evaluated. Likewise, the absence of reported results does not demonstrate that the intervention had no effect. The reasons for termination and the completeness of outcome follow-up are not reported, so no explanation for the missing comparison can be inferred.
The serious and other adverse-event entries list zero affected participants in each group, with the listed group counts at risk. These descriptive counts do not answer the primary efficacy question, and the record does not report a comparative safety analysis or death counts. Overall, the registry information permits a description of the planned comparison and the recorded event counts, but not a conclusion about the intervention’s effects on exercise frequency, self-management, readmission, or safety.
13. Why This Trial Matters Statistically
This trial is statistically notable because the registry record describes a randomized comparison but does not report the primary-outcome comparison. Randomization can support a clear group contrast when the assignment process, outcome definition, follow-up, and analysis are adequately documented. Here, the available entry identifies the broad design and endpoint, yet lacks the result needed to quantify that contrast. This distinction is important: a study’s question and rationale do not substitute for an analysis of observed outcomes.
The endpoint also illustrates why outcome definition matters. Exercise frequency is represented by telephone survey responses on a ranked scale, with the better outcome identified as 1. The record says that multiple categories or time points were not reduced to one comparison. Without the category-level results and a specified analytic approach, a reader cannot determine how responses were summarized or compare the groups on a common, interpretable scale.
The record’s 30 participants and its listed planning assumptions do not establish the precision of any result. Planning illustrations are distinct from trial-specific design justification, and neither can replace an observed effect estimate with uncertainty. General statistical interpretation: estimates and confidence intervals are needed to understand both the direction and precision of a comparison; a design label or enrollment figure alone cannot answer whether an observed difference is compatible with a range of values.
Finally, the terminated status and the absence of outcome results underscore the value of transparent reporting. The record does not state why the trial ended, whether outcomes were fully collected, or how multiplicity and missing data were addressed. These are not merely administrative details: they shape how readers can judge the reliability and scope of the evidence. The record is useful for identifying the trial’s question and design, while leaving its principal statistical conclusion unresolved.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation for interpreting this particular trial is that the registry record does not report the primary-outcome comparison. The primary outcome is described as a ranked telephone-survey measure at 3 months, but the record says it has several categories or time points and was not reduced to one comparison. Arm-level response data, a statistical contrast, and a precision measure are not reported. Consequently, the effect of video-enhanced education on the endpoint cannot be estimated from the posted results.
The outcome description leaves important measurement details unspecified. The wording of the telephone question, the interpretation of response categories other than the direction of the best outcome, and the method used to combine or analyze responses are not reported in the registry record. The record does not state whether survey assessors knew group assignment or identify who was masked under the single-masking label. These gaps prevent a detailed assessment of measurement and detection processes.
Enrollment was 30, but the record does not report participant flow, the number with observed outcomes, or the analysis population. Missing-data handling, the trial-specific sample-size justification, and any sensitivity analyses are not reported. Four outcome measures and three analyses are listed without a reported multiplicity plan. The reasons for termination, interim analyses, and stopping rules are also not reported in the registry record.
The intervention and usual-care descriptions include class invitations and possible referral to physiotherapy, but the record does not report actual attendance, referral, or adherence. It therefore does not show how much of the intended education or usual care participants received. Safety entries are limited to the listed counts and do not include a reported comparative analysis, event definitions, or completeness of ascertainment. These limitations constrain interpretation without establishing that any specific bias or problem occurred.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Effects of DVD Education on Physical Activity and Self Management of Heart Failure — NCT01622010.
- Registry record last updated 2021-05-25; status last verified 2021-05.
- Results first posted 2021-05-25.
- 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
NCT01622010 is a randomized, single-masked, parallel trial of education for people with heart failure. The comparison was standard care with video enhancement versus standard care. The video-enhancement arm received a copy of “Keeping the Beat with Physiotherapy: Heart Failure edition,” in addition to the standard-care description, which includes an invitation to an Allied Health Education Class and possible physician-requested physiotherapy referral.
Enrollment was 30. The primary outcome was general exercise frequency, assessed by telephone survey at 3 months using a ranked Likert scale from 1 to 4, with 1 representing the better outcome. The registry lists four outcome measures and three analyses. Its status is terminated; the reason is not reported in the registry record.
No primary-outcome comparison or secondary-outcome results are reported. The record lists zero participants affected by serious and other adverse events in each arm; death counts are not reported. The available information describes the trial design and outcome question but does not permit estimation of the intervention effect.