ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI) (NCT05240534), a randomized na study. The primary outcome is Physical Function as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.

2. Clinical Question

The study asks whether delivering an existing electronic health intervention through a voice-based smart system differs from delivering it through a text/typing-based laptop. ElderTree is described as offering tools, motivation, and support to help older adults manage their health. The registry’s stated rationale is that a voice-based system might encourage more consistent use; whether that happened is an empirical question, not something established by the rationale itself.

The primary outcome is physical function, a participant-reported measure of overall health and physical disability. Other registered outcomes include days of ElderTree use and PROMIS-43 measures of physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and social roles. The registry lists 20 outcome measures overall. It does not report analysis results for the primary outcome, so the direction, size, and precision of any difference between delivery approaches are not reported in the registry record.

3. Trial Design

The registry describes a randomized, double-masked, parallel-group trial with enrollment of 502 participants. The two behavioral intervention groups received ElderTree using different delivery systems: a laptop in the control group and a smart system in the experimental group. The registry lists the study status as completed and the phase as NA. It identifies the University of Wisconsin, Madison as sponsor.

The recorded study start date is 2022-04-29, and the primary completion date is 2025-12-03. The primary outcome schedule includes baseline and follow-up assessments at 6, 12, and 18 months. These scheduled assessments allow change and between-group patterns to be considered over time, but the registry does not report outcome estimates at those time points. It also does not report the allocation ratio, the practical procedures used to maintain masking, or whether the analysis followed the original assignment regardless of intervention use.

The study addresses multiple chronic conditions among older adults. Its background describes the burden of these conditions and the challenges of self-management, including treatment adherence and health tracking. It also frames delivery mode as a possible influence on how consistently participants use an electronic health intervention. Those points explain the question being tested; they do not establish that one delivery approach led to better outcomes.

Although the registry records 502 participants enrolled, that number is not an outcome-specific analysis count. The primary outcome description notes that participants did not return surveys at the 6, 12, and 18 month time points. The number of available responses at each assessment, the analysis population, and the handling of missing responses are not reported in the registry record. No primary outcome comparison or statistical analysis results are listed.

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: There were 115 participants enrolled during the period of April 2022-November 2022. Due to intervention no longer supported by the specific smart system device, recruitment was halted. No data collected after baseline. 387 participants were enrolled during the period of June 2023-April 2024.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All participants did not return surveys at 6, 12 and 18 month time points.

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 Physical Function as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1, measured over Baseline, 6, 12, 18 months.

The primary endpoint is physical function measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1. The outcome is expressed as a T-score and summarized as a mean, with standard error identified as the dispersion measure. The scheduled assessments are baseline, 6, 12, and 18 months.

The registry describes this measure as a participant-reported assessment of overall health and level of physical disability. Its scores are standardized to a general US population mean of 50 and a standard deviation of 10. Lower scores indicate worse outcomes. Standardization gives the score a reference scale, which can make it easier to interpret a group mean in relation to the stated population reference. It does not, by itself, show whether a difference between trial groups is important or attributable to the delivery system.

Physical function is relevant to the study’s focus on managing chronic health conditions because the registry identifies physical health and self-management as concerns for the population. The repeated assessment schedule could describe how the measure changes over time as well as how the groups compare. However, the registry record does not report the group means, changes from baseline, between-group estimates, confidence intervals, or tests for this endpoint. Consequently, the observed physical-function pattern and its precision are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization is a design method intended to create comparable groups at the point of assignment, on average, by using chance rather than selecting a delivery approach according to participant characteristics. In this trial, the registry identifies randomized allocation to two parallel groups. A parallel design means the groups receive their assigned approaches during the study rather than being described as sequential treatment periods for each participant. Randomization supports a between-group comparison, but does not guarantee that every measured characteristic will be identical between groups. The registry does not report the allocation procedure or the allocation ratio.

What does masking mean?

The registry labels the study double-masked. Masking is a design feature intended to limit the influence of knowledge about assignment on study conduct or outcome assessment. The record does not specify which people were masked, how masking was implemented, or whether it could be maintained given the different delivery systems. Those details are not reported in the registry record, so the label alone does not establish the practical success of masking.

How should the primary measure be read?

The primary endpoint is a continuous measure summarized as a mean. A mean describes the central level of scores in a group; it does not describe every participant’s experience or the full spread of individual scores. The registry identifies standard error as the dispersion measure. In general, a standard error describes the uncertainty in an estimated mean, rather than the variability of individual observations. The record does not provide the means or standard errors, so their values and precision cannot be interpreted.

The outcome is a PROMIS 29 v2.1 T-score. The registry states that the score is standardized against a general US population mean of 50 and standard deviation of 10, and that lower values indicate worse outcomes. These are scale-reference properties, not observed trial findings. The assessments are scheduled at baseline and follow-up, which could support analysis of change over time or comparison of trajectories. The statistical approach actually used for the repeated measurements is not reported in the registry record.

What does a confidence interval contribute?

In general, a confidence interval expresses uncertainty around an estimated quantity by giving a range of values compatible with the data under the assumptions of the analysis. Its width reflects precision: a narrower interval indicates greater precision than a wider interval for the same type of estimate. A confidence interval is not a guarantee that the true value lies within the particular interval, and its interpretation depends on the design and analysis. No confidence interval for the primary comparison is reported in the registry record.

What can a p-value tell a reader?

In general, a p-value assesses how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the analysis assumptions were true. It does not measure the probability that the null hypothesis is true, nor does it state the size or practical importance of a difference. A p-value is most informative alongside an effect estimate and its uncertainty. The registry record does not report a primary-outcome p-value or the associated analysis.

How should planning illustrations be understood?

The registry’s stated sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is described as a fraction of the observed effect. These are planning assumptions, not evidence about the trial’s results. The illustrations are not observed power. In general, power is a design-stage probability tied to specified assumptions, not a measure of how persuasive an observed result is after a study is complete. The numerical planning outputs and the observed effect used for them are not reported in the registry record.

More broadly, a statistical method needs to be matched to the outcome, design, follow-up, and missing-data structure. The primary endpoint is continuous and repeatedly assessed, but the record does not identify a fitted model, covariate adjustment, treatment of baseline scores, handling of within-participant correlation, or decision rule for the primary comparison. These methods are not reported in the registry record. As a result, the posted information supports a description of the design and measurement, but not a reconstruction or independent evaluation of the primary statistical analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 20 outcome measures, including the primary physical-function outcome and secondary outcomes covering intervention use and several health domains. When a study evaluates multiple outcomes, time points, or comparisons, the chance of at least one apparently notable result can increase if each is interpreted separately. In general, multiplicity procedures may be used to control that risk, or outcomes may be organized into a prespecified testing hierarchy. The registry record does not report whether any multiplicity adjustment or hierarchy was used.

The primary outcome is scheduled at baseline and 6, 12, and 18 months. The registry’s skip information indicates that the primary outcome has several categories or time points and was not reduced to one comparison. No analysis results are listed. The primary analysis time point, any overall test across time, and the approach to multiple comparisons are not reported in the registry record.

The primary outcome description notes that participants did not return surveys at the 6, 12, and 18 month time points. It does not give the number of missing surveys at each visit, the reasons for non-return, or whether missingness differed between groups. It also does not report whether analyses used complete cases, imputation, a likelihood-based method, or another approach. Missing data can affect interpretation when participants with observed outcomes differ from those without observed outcomes; that is a general concern, not a claim about why surveys were absent in this trial.

The registry records 502 participants enrolled, but does not report the number included in each primary-outcome analysis or the definition of that analysis population. Whether participants were analyzed according to randomized assignment is not reported in the registry record. Without these details, the role of missingness and the scope of the primary comparison cannot be assessed from the registry information.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event figures are reported separately for the ElderTree on Laptop group and the ElderTree on Smart System group. The registry lists 188 participants at risk in the laptop group and 199 in the smart-system group. It reports zero participants affected by serious adverse events and zero affected by other adverse events in each group. The listed deaths are 5 in the laptop group and 2 in the smart-system group.

These counts should be read as registry reporting, not as evidence that the intervention caused or prevented an event. The death counts are presented separately from the serious and other adverse-event counts; the record does not say that the deaths were attributed to the intervention. It also does not report causes, timing, event definitions, exposure time, or an analysis comparing event rates. The absence of affected participants in the two adverse-event categories therefore does not establish that no events occurred beyond what was recorded or that the approaches have equivalent safety.

The registry lists no top serious adverse-event terms. Safety interpretation is limited to the reported group counts and the information accompanying them. The relation of the death counts to study follow-up and any attribution assessment is not reported in the registry record.

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

The registry establishes that a randomized, double-masked, parallel-group trial compared ElderTree delivered on a laptop with ElderTree delivered on a smart system in older adults with multiple chronic conditions. It identifies physical function measured with PROMIS 29 v2.1 T-scores as the primary outcome and specifies assessments at baseline, 6, 12, and 18 months. These details identify the clinical question and measurement framework.

They do not establish which delivery approach produced better physical-function scores. The registry record does not report group estimates, a between-group effect, confidence intervals, or a statistical test for the primary endpoint. It also does not report outcome findings for the listed secondary measures. Thus, no conclusion about the direction, size, or precision of differences can be drawn from the posted results.

The trial’s rationale suggests that a voice-based platform might support more consistent intervention use. That proposal is not a finding. The registry lists ElderTree days of use among the secondary outcomes, but does not report the result. Likewise, the background describes potential burdens associated with multiple chronic conditions; this context does not show that either delivery approach changed those burdens.

The registry reports zero participants affected by serious adverse events and zero affected by other adverse events in each group, alongside separate death counts. These data are descriptive, and the record does not provide attribution or comparative safety analyses. They should not be interpreted as proof of no risk or as evidence of a causal difference in deaths.

In general, a trial result is best interpreted using the estimated effect, its uncertainty, the analysis population, and the handling of missing data. Those elements are not reported for the primary endpoint in the registry record. The defensible conclusion is therefore limited: the study was designed to compare two ElderTree delivery approaches, but the posted registry information does not report the outcome analyses needed to describe what the comparison found.

13. Why This Trial Matters Statistically

This study poses a useful statistical question about delivery format rather than comparing different named health interventions. Both groups were assigned ElderTree, while the delivery system differed: laptop versus smart system. That design focuses the intended comparison on how the intervention is delivered. It also makes clear why outcomes related to use, including ElderTree days of use, are relevant alongside physical function.

The study uses a participant-reported continuous measure with a stated reference scale and repeated assessments. Such outcomes can be described through group means and changes over time, but the interpretation depends on the estimated differences and their uncertainty. A standardized score does not substitute for a treatment-effect estimate. Because those results are not reported in the registry record, the central statistical question remains unresolved in the posted information.

Missing follow-up surveys are particularly relevant for a longitudinal comparison. The record notes non-return at the 6, 12, and 18 month time points but does not state how many observations are available or how missingness was handled. These details are necessary to understand which participants contribute to the estimates and how robust the results may be to incomplete follow-up.

The registry also identifies 20 outcome measures. This makes clarity about the primary comparison and any multiplicity strategy important: multiple outcomes and time points can complicate interpretation if each is treated as an independent opportunity to identify a difference. The analysis plan and findings needed to evaluate that issue are not reported in the registry record.

More generally, the trial illustrates that a completed study registration and enrollment total do not by themselves communicate an intervention effect. Statistical interpretation requires outcome estimates, precision, analysis details, and transparent accounting of missing data. Those elements are not available for the primary comparison in the posted record.

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 interpreting the trial is that the registry record does not report the primary physical-function results or statistical comparison. Without group means, an effect estimate, confidence intervals, or a test result, the size and precision of any difference between delivery approaches cannot be assessed. The listed enrollment of 502 does not resolve that limitation.

The primary outcome description notes that participants did not return surveys at 6, 12, and 18 months, but does not quantify missingness by visit or group. Reasons for non-return, the number of participants contributing to each analysis, and the method used to address missing measurements are not reported in the registry record. This prevents assessment of how incomplete follow-up may affect the longitudinal comparison.

The record also does not report the statistical model, the primary contrast, baseline adjustment, analysis population, or handling of repeated measurements. Although 20 outcome measures are listed, multiplicity procedures and the relationship among primary and secondary analyses are not reported. These omissions make it difficult to evaluate the analysis strategy or distinguish planned testing from exploratory comparisons.

Masking is recorded as double, but who was masked and how masking was maintained are not reported in the registry record. The allocation ratio and randomization procedure are also not described. For safety, the record lists event counts but does not provide event timing, causes, exposure duration, attribution, or comparative analyses. These limits mean that the registry information supports a description of trial structure and reported counts, but not a full appraisal of outcome or safety findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI) — NCT05240534.
• Registry record last updated 2026-10-20; status last verified 2026-09.
• Results first posted 2026-10-20.
• 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

NCT05240534 is a completed randomized, double-masked, parallel-group behavioral study sponsored by the University of Wisconsin, Madison. It enrolled 502 participants and compared ElderTree on a laptop with ElderTree on a smart system for older adults with multiple chronic conditions. The recorded study start date is 2022-04-29, and the primary completion date is 2025-12-03.

The primary outcome is physical function measured by PROMIS 29 v2.1 T-scores at baseline and 6, 12, and 18 months. The registry lists 20 outcome measures, including ElderTree days of use and PROMIS-43 health measures. It notes survey non-return at follow-up but does not report the numbers missing or the analysis used to address missingness.

No primary outcome estimates or analysis results are listed in the registry record. Serious and other adverse-event counts are reported as zero affected participants in both groups; deaths are reported separately as 5 in the laptop group and 2 in the smart-system group. The record does not report attribution or comparative safety analyses.