Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System (NCT01275846), a na na study. The primary outcome is Percentage of Days Participants Measured Vitals and Completed Protocol Sessions.

2. Clinical Question

The study’s stated purpose was to ascertain whether remote patient management using American Heart Association guideline-based heart failure protocols and educational content could improve management of people with congestive heart failure. Its primary endpoint focuses on participant interaction with the monitoring system: whether vital signs were recorded and protocol sessions completed on days when monitoring was possible.

This is a question about use of the device and its associated content, rather than a comparison of clinical outcomes between alternative treatments. The registry also lists two quality-of-life outcomes using the Kansas City Cardiomyopathy Questionnaire: change in mean Clinical Summary Score and change in mean Overall Score. Their results are not reported in the registry record. The record does not report a comparator, so any changes over time cannot be separated from other influences using a controlled comparison.

3. Trial Design

This completed study enrolled 26 participants with heart failure and used a single-group model. The intervention was the Intel Health Guide with American Heart Association heart failure protocols and content. Allocation is listed as NA, and masking is listed as NONE. The registry lists the phase as NA. There was no separate control arm, so the study design does not support a direct comparison between participants receiving the device and participants receiving an alternative or usual-care condition.

The study began in 2010-06 and had a primary completion date of 2011-01. The registry status is COMPLETED. The intervention description identifies a telehealth device, customized heart failure protocols, response algorithms, and educational content. It also says participants interacted with the device and received immediate feedback when transmitting vital signs. More detailed information about how the device was used, the frequency of contacts, or the specific protocol rules is not reported in the registry record.

The primary endpoint was assessed over 60 days and concerns the percentage of available days on which vital signs were measured and recorded and protocol sessions completed. Two secondary outcomes concern change in KCCQ quality-of-life scores. The registry lists 4 outcome measures but 0 analyses. It does not report the statistical analysis plan, the analysis populations, or numerical results for the primary or secondary outcomes. Consequently, the design and endpoint can be described, but the registry record does not permit an assessment of the size or precision of any reported change.

Because there is no concurrent comparison group, changes during monitoring would be descriptive of this cohort and period. They could not, by themselves, establish that the device or its content caused any change. The registry does not report a sample-size justification or further design rationale.

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 Percentage of Days Participants Measured Vitals and Completed Protocol Sessions, measured over 60 days.

The primary endpoint is the mean percentage of available days during the 60-day monitoring period on which participants measured and recorded their vital signs and completed protocol sessions. The vital signs named in the endpoint description are weight, blood pressure, blood oxygen saturation level, and glucose level. The registry defines utility as days of participant activity and interaction with the monitor divided by days when monitoring was actually possible.

This endpoint is used to describe engagement with the remote monitoring system. In general, recording activity relative to days when monitoring was possible distinguishes device use from days that were not available for monitoring, according to the endpoint’s stated definition. It does not directly measure heart failure status, clinical benefit, or quality of life. Those are different questions and would require relevant outcome data.

The registry specifies a mean and full-range dispersion for this endpoint, but it does not report the numerical mean or range. It also does not report how days with incomplete measurements were handled, how the individual activity and interaction components were combined, or how the mean was calculated if participants had different numbers of available monitoring days. The primary endpoint result and its precision therefore cannot be interpreted from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary endpoint summarize?

The endpoint is specified as a mean: each participant’s activity is expressed as a percentage of available monitoring days, and the endpoint summarizes those percentages with a mean. The activity definition includes measuring and recording vital signs and completing protocol sessions. The denominator is described as days when monitoring was actually possible. The record does not explain whether every participant contributed the same number of available days or how partial completion of a day or session was classified.

In general, a mean gives a central summary but does not show how individual observations are distributed. The registry specifies full-range dispersion, which in general refers to the lowest and highest observed values. A range can indicate spread, but it does not describe how observations are distributed between its endpoints. Neither the mean nor the range is numerically reported in the registry record, so the endpoint’s observed level and variability are not available for interpretation.

What would a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the analysis. It is distinct from a range of participant values: a range describes observed variation, while a confidence interval concerns uncertainty in an estimate. The registry record does not report a confidence interval for the primary endpoint, nor does it provide an inferential analysis for the listed KCCQ outcomes. Statistical precision therefore cannot be evaluated from the record.

What is over-dispersion, and is it relevant?

In general, over-dispersion occurs when observed variability is greater than a statistical model expects. It can make standard errors too small and confidence intervals too narrow if a model does not account for that extra variation. This concept can matter for outcomes recorded as counts or proportions, depending on the model and data structure. The registry record does not describe a model for the primary endpoint, provide participant-level data, or report a dispersion estimate that would allow an assessment of over-dispersion in this study. It would therefore be inappropriate to claim that over-dispersion was present or was addressed.

What can the design say about changes?

In general, a single-group study can describe measurements within the enrolled cohort, but a change over time alone does not show what would have happened without the intervention. Without a separate comparison group, temporal changes and other influences cannot be distinguished from an effect attributable to the device. This limitation applies to both the activity endpoint and the listed KCCQ change outcomes. No randomized comparison or adjusted comparison is reported in the registry record.

How should sample-size illustrations be read?

In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability, significance level, allocation, and analysis method. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Time-to-event calculations are described as total event counts; other calculations are described as participants per arm. Such illustrations are not the study’s observed power and should not be interpreted as the study’s actual planned enrollment or as evidence that a result was statistically significant. The registry record does not report the study’s own sample-size justification. With no numerical primary result or analysis reported, the observed effect used in any planning illustration cannot be evaluated from the registry record.

More broadly, the registry record does not describe the statistical methods used to analyze the primary endpoint, the KCCQ outcomes, or the safety events. Details such as model choice, handling of repeated measurements, confidence-interval construction, and adjustment for baseline values are not reported in the registry record. Statistical methods should not be inferred from the endpoint labels alone.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 4 outcome measures, including the primary activity endpoint and two secondary KCCQ change outcomes. It lists 0 analyses. The record does not describe a prespecified hierarchy among outcomes, an adjustment for multiple comparisons, or how interpretation would account for testing more than one outcome. In general, evaluating multiple outcomes can increase the chance of at least one apparently notable result when each is tested separately. Whether that concern affected this study’s analyses cannot be determined because the analyses and their results are not reported.

Missing-data methods are not reported in the registry record. The primary endpoint uses days when monitoring was actually possible as its denominator, but the record does not explain how unavailable days were identified or how incomplete vital-sign records and protocol sessions were treated. It does not report participant-level monitoring completeness, exclusions, or whether all enrolled participants contributed to the endpoint.

The registry record also does not report the analysis populations for the primary or secondary outcomes, or how missing KCCQ measurements were handled. It is therefore unclear whether results, if analyzed, would have included all enrolled participants or a subset with available measurements. No assumptions about missingness or sensitivity analyses are reported. These omissions matter because an analysis of only participants with complete observations can represent a different group from the original cohort if completeness is related to participant characteristics or outcomes. This is a general statistical concern, not a finding about this study.

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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: rehospitalization (34.6%).

The registry’s safety group is titled “Health Guide Using AHA Protocols.” It lists 26 participants at risk for serious adverse events and 13 with serious adverse events. For other adverse events, it lists 26 at risk and 0 affected. It also records 1 death. These are counts as recorded for the study group; the record does not provide enough detail to determine whether categories overlap or how the death relates to the serious-event count.

Rehospitalization is listed among the top serious-event terms at 34.6%. The registry record does not state the denominator or further context for this percentage, so it should be read as the listed percentage for that term rather than recalculated or assigned a different interpretation. Event timing, severity criteria, and relatedness to the device are not reported in the registry record.

These safety figures are descriptive. In a single-group study without a control arm, they cannot establish whether the intervention caused or prevented an event. The counts also do not by themselves characterize the participants’ underlying risk or the circumstances surrounding each event. No causal conclusion follows from the registry’s event listing.

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

The registry record establishes that a completed, single-group study enrolled 26 participants and evaluated use of an Intel Health Guide with American Heart Association heart failure protocols and educational content. It defines a primary endpoint based on participant activity over 60 days and identifies two secondary KCCQ change outcomes. It also records safety counts for the intervention group.

The record does not report the numerical result for the primary endpoint, the KCCQ outcome results, or any statistical analyses. As a result, it does not establish the degree of device use, the size or direction of any quality-of-life change, or the precision of an estimated outcome. The endpoint descriptions alone are not outcome findings. The recorded safety events likewise cannot be attributed to the device based on the information in the record.

Even if within-participant changes had been reported, the single-group design would limit causal interpretation. Without a separate comparison group, the study could not distinguish changes associated with the monitoring system from changes that might have occurred for other reasons. The registry record also does not report details of missing-data handling or analysis populations, which further limits interpretation of any potential estimates.

In general, evidence about feasibility or participant interaction is different from evidence about clinical outcomes, and evidence of change in one cohort is different from evidence of a causal treatment effect. The registry’s endpoint definition addresses interaction with the monitor; it is not itself a measure of clinical benefit. The available record supports these distinctions but does not support a conclusion that the intervention did or did not improve heart failure management.

13. Why This Trial Matters Statistically

This study illustrates why an endpoint’s definition and an endpoint’s result must be kept separate. The primary outcome is clearly framed as participant activity relative to days when monitoring was possible, but the numerical mean and full range are not reported in the registry record. Without those results, readers cannot judge the level of engagement or how much it varied across participants.

The study also demonstrates the inferential limits of a single-group design. Even a measured change in device use or quality of life would not, on its own, identify the cause of that change. A comparator can help distinguish changes associated with an intervention from changes over time or other influences; this record reports no separate comparison group. This is a design limitation, not a reason to infer an unreported outcome.

Finally, a registry entry may identify outcomes and safety counts without providing the analyses needed to assess estimates and uncertainty. Here, the record lists 4 outcome measures and 0 analyses. It gives safety counts but does not report event relatedness or detailed context. These distinctions are important when interpreting a study: a defined endpoint is not a result, a count is not a causal assessment, and a planning illustration is not observed power. The registry record is therefore informative about the study’s structure and reporting gaps, but not about the magnitude or precision of outcome effects.

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 available record leaves important details about both the intervention and its evaluation unreported. It describes the Intel Health Guide, customized protocols, response algorithms, educational content, and immediate feedback when participants transmitted vital signs. It does not provide further detail about the device workflow, protocol content, or the amount of interaction expected. Those details would help readers understand what exposure the activity endpoint represents.

The single-group model and lack of a separate control group limit causal interpretation. The registry does not report randomization, a comparison condition, or an adjusted analysis. Allocation is listed as NA. The sample-size justification, statistical plan, analysis populations, and missing-data procedures are not reported in the registry record.

Most importantly, the numerical primary endpoint result and the KCCQ results are not reported, and the record lists 0 analyses. The primary endpoint specifies full-range dispersion, but the mean and range are absent. The record also does not explain the denominator in practice, the treatment of partially completed sessions, or whether all enrolled participants contributed data. These omissions prevent evaluation of the endpoint’s magnitude and variability.

The safety information gives group counts and a rehospitalization percentage but does not report timing, detailed event definitions, or relatedness to the intervention. These limitations are specific to the information in the registry record; they do not establish that additional information was unavailable elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System — NCT01275846.
• Registry record last updated 2022-03-31; status last verified 2022-03.
• Results first posted 2022-03-31.
• 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

NCT01275846 is a completed, single-group study sponsored by the American Heart Association. It enrolled 26 participants with heart failure and evaluated an Intel Health Guide telehealth device using American Heart Association heart failure protocols and content. The study began in 2010-06 and had a primary completion date of 2011-01. Masking is listed as NONE, allocation as NA, and phase as NA.

The primary endpoint was the mean percentage of available days during 60 days on which participants recorded vital signs and completed protocol sessions. Two listed secondary outcomes measure change in KCCQ Clinical Summary Score and Overall Score. The registry lists 4 outcome measures and 0 analyses; numerical outcome results are not reported in the registry record.

The safety group lists 13 participants with serious adverse events among 26 at risk, 0 with other adverse events among 26 at risk, and 1 death. Rehospitalization is listed among the top serious-event terms at 34.6%. The record does not establish event causality.