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 Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study (NCT03832192), a randomized phase 2 study. The primary outcome is Incident Delirium Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03832192 |
| Phase | Phase 2 |
| Condition | Delirium, Fall Injury |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 301 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Victor Wang |
| Results posted | Yes |
2. Clinical Question
Population
The primary question concerns hospitalized patients without prevalent delirium at enrollment who also had a final Confusion Assessment Method screen on record. The registry describes enrollment screening as occurring within 24 hours of admission to the hospital unit and follow-up screening at least daily. The primary endpoint definition focuses on patients who screened negative at enrollment and had a final screen recorded.
Intervention
The intervention was a care.coach avatar platform incorporating protocols based on the Hospital Elder Life Program. The study description says the platform was designed to provide psychosocial support and protocol-driven interventions, with integration into hospital electronic medical record systems.
Comparator
The comparator was usual care only. The registry identifies the study as a randomized, parallel-group comparison, with the avatar intervention compared against the control group across participating hospitals.
Primary question
The primary question was whether the rate of incident delirium differed between the avatar intervention and usual care during each participant’s inpatient stay. Incident delirium was defined as any positive CAM screen after a negative enrollment screen. The registry describes the intended direction as a lower rate, but the posted counts and comparison estimate indicate the observed direction in this trial.
The study also aimed to assess falls and patient sitter utilization and to collect data for future development of automated protocol assignment and delirium screening. Those broader aims are not the primary endpoint reported in the posted results. The primary comparison is based on participants without prevalent delirium who had a final CAM screen recorded, rather than every person in the overall enrollment figure. The registry record does not explain the reason for the difference between the total enrollment and the primary endpoint group sizes.
3. Trial Design
This was a Phase 2, randomized, single-masked, parallel-group study. The registry lists enrollment of 301 and a completed study status. The recorded start date is 2019-01-08, and the primary completion date is 2021-01-07. The study description characterizes the comparison as lasting two years and involving multiple hospitals. It identifies Jamaica Hospital Medical Center in the MediSys Health Network as the initial research site, with additional hospitals expected to join during the study.
The intervention was the care.coach Avatar (HELP-Protocolized), described as a behavioral intervention. The control group received usual care only. The registry reports the randomized allocation and single masking, but the identity of the masked parties is not reported in the registry record. Further details about the randomization procedure, allocation concealment, and implementation of masking are not reported in the registry record.
The primary outcome was incident delirium, assessed with CAM screening from study enrollment through discharge. The timeframe is described as the beginning to the end of each participant’s inpatient stay, with an average of 4 days. The primary results include 87 intervention participants and 65 control participants. These endpoint group sizes are smaller than overall enrollment; the registry record does not explain how participants were selected for the endpoint population or why records were unavailable for others.
The study also lists delirium resolution rate and change in cognitive function as secondary outcomes. Numerical results are posted for change in cognitive function, while quantitative results for delirium resolution are not reported in the registry record. The registry contains no reported analyses for the primary outcome. It does post an unadjusted comparison for the primary endpoint and an unadjusted comparison for cognitive function.
The registry describes the project as seeking to validate the avatar platform and gather patient and outcome data for future algorithm development. The specific protocol details, sample-size justification, and full statistical analysis plan are not reported in the registry record. The planning figures associated with the cognitive comparison are illustrations based on the observed effect, not the design basis or observed power of this trial.
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 | Intervention | Control |
|---|---|---|
| STARTED | 152 | 149 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 152 | 149 |
Reasons for not completing this period:
| Reason | Intervention | Control |
|---|---|---|
| Participants are disenrolled upon hospital discharge. | 152 | 149 |
Analysis population for the primary outcome, as defined in the registry: Patients without prevalent delirium and have a final CAM screen on record
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 | Intervention | Control | Total |
|---|---|---|---|---|
| Participants analysed | 152 | 149 | 301 | |
| Age, Continuous | years | 76 (SD 9) | 75 (SD 8) | 76 (SD 9) |
| Sex: Female, Male: Female | Participants | 76 | 58 | 134 |
| Sex: Female, Male: Male | Participants | 76 | 91 | 167 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 26 | 26 | 52 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 119 | 117 | 236 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 7 | 6 | 13 |
| Short Portable Mental Status Questionnaire | number of questions incorrectly answered | 2.0 (SD 1.8) | 2.6 (SD 2.4) | 2.3 (SD 2.1) |
| Confusion Assessment Method | number of positive screens | 23 | 8 | 31 |
| Memorial Delirium Assessment Scale | scores on a scale | 8.2 (SD 4.6) | 14.3 (SD 4.6) | 12.6 (SD 5.3) |
6. Primary Endpoint
The registry lists the primary outcome as Incident Delirium Rate, measured over From beginning to end of each participant's inpatient stay, an average of 4 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
Incident delirium is a binary outcome: for each eligible participant, the endpoint records whether any CAM screen became positive after a negative enrollment screen. A participant with at least one positive screen during the study period is counted as having incident delirium; a participant without a positive screen is not. The registry says CAM assessments were performed at least daily, beginning after enrollment and continuing through the final screen near discharge.
This endpoint is used to measure newly identified delirium among patients who did not screen positive at enrollment. Restricting the endpoint population in this way distinguishes incident cases during the inpatient stay from delirium already present at the start of study observation. A final CAM screen on record is also part of the stated population definition.
The posted primary result counts 6 intervention participants with incident delirium among 87 and 0 control participants among 65. The registry’s comparison is expressed as a risk difference, with the intervention group’s observed event proportion higher than the control group’s. This describes the recorded endpoint during the study period; it does not establish why the groups differed or whether the difference would persist in another setting.
The endpoint’s interpretation depends on the screening process and on which participants have usable enrollment and final assessments. The registry describes the intended screening schedule but does not report adherence to that schedule, the completeness of screening across groups, or details of adjudication. Those details are not reported in the registry record.
7. Results Posted in the Registry
- Intervention: 6.9% (6/87) versus 0.0% (0/65) on control; risk difference 6.9 percentage points (95% CI 1.6 to 12.2); unadjusted two-proportion z-test p = 0.031.
Risk difference: Intervention
95% CI: 1.6 to 12.2 percentage points
Recalculated from the posted summary statistics
8. Secondary Efficacy Endpoints
The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.
| Secondary outcome | Type | Effect measure | Estimate (95% CI) | Planning size, 80% power |
|---|---|---|---|---|
| Change in Cognitive Function | Continuous Endpoint | Mean difference | 0.29 (-0.39 to 0.97) | 811 per arm |
Change in Cognitive Function
- Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
- Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
- Result:
- Intervention: mean 0.14 versus -0.15 on control; difference 0.29 (95% CI -0.39 to 0.97), standardized effect d = 0.14; z-test p = 0.406.
- Interpretation:
- The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention and the control. The interval gives the range of effects that remain compatible with the data.
The registry lists delirium resolution rate and change in cognitive function as secondary outcomes. Of these, quantitative results are reported for cognitive function; numerical results for delirium resolution are not reported in the registry record. The posted cognitive comparison does not provide clear evidence of a group difference: its interval includes zero and its unadjusted p-value is 0.406. This is a different outcome from incident delirium, so it should be interpreted on its own terms rather than as a direct replication of the primary endpoint.
The pattern across the available results is therefore not a consistent set of demonstrated benefits across outcomes. The primary endpoint has an observed direction toward more incident delirium in the intervention group, while the reported cognitive comparison does not establish a group difference. That contrast does not identify a mechanism or show that one outcome explains another. The registry does not report participant-level associations linking incident delirium to cognitive change.
Secondary outcomes generally carry less weight than a prespecified primary outcome because they may be among multiple opportunities to observe a difference. When many outcomes are examined, some results can appear notable by chance. The registry does not report a multiplicity adjustment, a hierarchy of secondary hypotheses, or a complete analysis plan. The cognitive comparison is also unadjusted, and its interpretation should remain exploratory rather than conclusive.
The study description also mentions falls and patient sitter utilization as aims, but numerical results for those outcomes are not reported in the registry record. Their absence prevents a balanced assessment of the broader stated aims from the posted results. Likewise, the absence of a quantitative delirium-resolution result means that the available secondary evidence cannot characterize that outcome’s direction or precision.
In general, secondary findings can help frame the scope and consistency of a trial’s evidence, but they should not replace the primary endpoint or be treated as independent confirmation without a suitable analysis plan. In this study, the registry does not provide enough detail to determine how secondary outcomes were prespecified or how missing observations were handled.
Secondary outcomes registered for this trial, for reference (only those above were recalculated):
- Delirium Resolution Rate
- Change in Cognitive Function
9. Statistical Interpretation
The posted primary outcome is based on 6 incident delirium cases among 87 intervention participants and 0 among 65 control participants. The reported risk difference is 0.069, with a confidence interval entirely on the positive side, and the unadjusted p-value is 0.031. In the observed data, incident delirium was more frequent in the avatar group than in the usual-care group. This direction is opposite to the lower event rate identified as desirable in the endpoint description.
The result is an estimate from the participants included in the primary outcome analysis, not from all 301 enrolled participants. The registry does not explain the distinction between overall enrollment and the endpoint denominators. It is therefore important not to treat the endpoint group counts as a complete account of every randomized participant or to assume a reason for the difference.
The risk difference expresses the observed separation between the two event proportions on an absolute scale. It does not adjust for other participant characteristics or account for other possible sources of bias. The posted p-value is explicitly unadjusted. It describes compatibility of the observed data with a no-difference statistical model under the analysis used; it is not the probability that the intervention is effective, that the null hypothesis is true, or that the finding will recur.
The event counts are small, particularly in the control group, where no incident delirium cases are recorded. With sparse binary outcomes, the estimate can be sensitive to a small number of events, and the interval conveys substantial uncertainty even though it excludes zero as reported. The interval does not capture every possible source of uncertainty, such as incomplete outcome ascertainment or differences in care across hospitals.
The cognitive-function result does not show a clear separation between groups in the posted unadjusted analysis. Its reported interval includes no difference, and its p-value is 0.406. This secondary result should not be used to overturn or confirm the primary finding: it addresses a different outcome and is one among multiple study aims. The registry lists delirium resolution as another secondary outcome but does not report its quantitative result.
The data support a description of the observed group contrast, not a causal conclusion that the avatars increased delirium. Randomization is a strength in principle, but interpreting the posted result also requires information on analyzed populations, missing assessments, adherence, and the prespecified analysis plan. Those details are not reported in the registry record. No medical conclusion follows from these registry results alone.
10. Statistical Methods Explained
The primary endpoint is binary because each eligible participant is classified as either having or not having incident delirium during the observation period. For a binary outcome, the event proportion is the number of participants with the event divided by the number assessed in that group. The posted comparison uses a risk difference, which expresses the intervention event proportion minus the control event proportion. A positive estimate means the event proportion was higher in the intervention group in this comparison; a negative estimate would mean it was lower. The posted estimate is 0.069.
What does the confidence interval describe?
In general, a confidence interval gives a range of values compatible with the data and the method used to calculate it. It conveys uncertainty in an estimated contrast, rather than a range containing a fixed percentage of individual outcomes. For the primary risk difference, the reported interval lies above zero. That means the interval from the posted method does not include an equal event proportion as a plausible value at its stated confidence level. The registry record does not provide enough detail to assess every assumption behind the interval calculation.
What does the p-value describe?
In general, a p-value measures how unusual data at least as discrepant as those observed would be under a specified statistical model in which there is no group difference. It is not a measure of effect size, clinical importance, or the probability that a treatment hypothesis is true. The primary comparison has an unadjusted p-value of 0.031. The word unadjusted matters because the registry does not report a correction for examining multiple outcomes or analyses. The test specification and whether this was the sole prespecified primary analysis are not reported in the registry record.
Why do event counts matter?
When the outcome is uncommon or event counts are sparse, a small number of observations can have a substantial influence on the estimated group contrast. The primary result includes 6 events in the intervention group and none in the control group. A zero event count does not demonstrate that the underlying event probability is zero; it means no event was recorded among the analyzed control participants. Sparse data also make uncertainty and the choice of statistical method especially relevant. The registry record does not identify the exact test or interval procedure used for the posted primary comparison.
How should the cognitive comparison be read?
Change in cognitive function is a continuous outcome summarized by group means and standard deviations. A mean difference compares the average change in the intervention group with the average change in control. The posted estimate is 0.29, and the reported interval extends across zero; the unadjusted p-value is 0.406. In general, a standard deviation describes variation among participant measurements, while the standard error describes uncertainty in an estimated mean. These quantities answer different questions and should not be interchanged. The registry reports group standard deviations and standard errors for this outcome.
What are the planning figures?
The sample-size illustration for cognitive function uses the observed effect as a reference and presents planning for 100%, 75%, and 50% of that observed effect. It reports participants per arm for 80% power and participants per arm for 90% power. The assumptions stated in the registry are a two-sided significance level of 0.05, equal allocation, and a normal approximation. The resulting figures are planning illustrations, not observed power and not evidence that the original trial was designed with those assumptions. The registry explicitly says the illustration is computed from the observed effect, not the trial’s own design. Smaller effects require larger planned groups under this illustration; this is a general relationship in power calculations, not a new calculation of trial results.
What does over-dispersion mean in general?
Over-dispersion occurs when observed variability exceeds what a statistical model assumes. It can make standard errors too small if the model does not account for the extra variability, which can make intervals too narrow and p-values too small. The primary outcome is binary and no dispersion estimate is reported for it. Over-dispersion is therefore a general statistical concept, not a reported feature of this trial’s primary analysis. The continuous secondary outcome is summarized with standard deviations, but the registry does not report a separate over-dispersion assessment.
Across outcomes, the analysis details needed to reproduce the reported estimates are incomplete. The registry does not report the primary test procedure, covariate adjustment, handling of missing outcome data, or an analysis population definition beyond the endpoint population description. These omissions limit assessment of robustness and do not justify filling in the missing methods by assumption.
11. Confidence Intervals and Precision
The primary risk-difference estimate is 0.069. Its reported confidence interval lies entirely above zero, so the interval indicates a positive observed difference under the method used. The interval is also broad enough that the data do not identify a single precise value for the underlying group contrast. Precision should be judged from the interval as well as the point estimate, rather than from the p-value alone.
The interval reflects uncertainty in the estimated risk difference from the analyzed groups, but it does not automatically address uncertainty due to missing assessments, selection into the analysis population, or differences in outcome measurement. The primary endpoint includes 87 intervention participants and 65 controls, while overall enrollment is 301. The registry record does not explain this difference or report how many participants lacked the required screening information.
The observed control group has no incident delirium cases. That zero count is a feature of the analyzed data, not proof that the underlying risk is zero. With few total events, the point estimate can be influenced by individual observations, and the uncertainty interval should temper any strong interpretation of the size of the contrast.
For cognitive function, the reported mean-difference interval includes zero, so the posted data are compatible with no average difference as well as with values on either side of zero. The unadjusted p-value of 0.406 similarly does not establish a group difference. These intervals are estimates of statistical precision, not guarantees about future results or the range of individual participant changes.
Neither confidence interval captures all uncertainty in generalizability. The study involved participating hospitals, and the registry describes an initial site with additional hospitals to join. The record does not report site-specific estimates or enough detail to assess variation across hospitals. The precision estimates should therefore be read as conditional on the recorded analysis and its participants, not as a complete measure of uncertainty about outcomes in all hospital settings.
12. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple outcomes, including incident delirium, delirium resolution, cognitive function, falls, and patient sitter utilization. It reports an unadjusted primary comparison and an unadjusted cognitive comparison. An adjustment for multiplicity, a testing hierarchy, or a plan controlling the overall chance of false-positive findings is not reported in the registry record. Without such information, the p-values should be viewed as outcome-specific, unadjusted results rather than as results from a documented family-wide testing strategy.
The registry identifies the primary population as patients without prevalent delirium who had a final CAM screen on record. It reports 87 intervention and 65 control participants for that endpoint. The overall enrollment is 301. The record does not provide a flow of participants from enrollment through randomization, follow-up, and analysis, and it does not explain the difference between the overall enrollment and the primary endpoint denominators. The reason for the analyzed sample sizes is therefore not reported in the registry record.
The cognitive comparison includes 87 intervention participants and 68 controls. The record does not explain why its control denominator differs from the primary endpoint control denominator. It also does not report the number or pattern of missing cognitive assessments, the method used to handle missing data, or whether any imputation was performed. No assumptions about complete-case analysis or imputation can be made from the posted information.
The registry does not state whether the primary analysis followed an intention-to-treat principle, define a per-protocol population, or describe exclusions after randomization. It also does not report the primary model, adjustment for site or baseline characteristics, or prespecified sensitivity analyses. Although the study is described as randomized and single-masked, the record does not identify who was masked or how masking was maintained.
These reporting gaps affect interpretation, not just reproducibility. Missingness or post-randomization exclusions can change which participants contribute to an estimate, and multiple unadjusted comparisons complicate interpretation of isolated p-values. The registry record does not contain enough information to determine the direction or magnitude of any such effects.
13. 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 |
|---|---|---|---|
| Intervention | 0 | 152 | 0.0% |
| Control | 0 | 149 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention | 0 of 152 |
| Control | 0 of 149 |
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 |
|---|---|
| Intervention | 0 of 152 |
| Control | 0 of 149 |
The registry reports no serious adverse events in either safety group: 0 among 152 intervention participants at risk and 0 among 149 control participants at risk. It also reports no other adverse events in those groups and no deaths. No top serious adverse-event terms are listed.
These are counts within the reported safety populations. They do not mean that the risk of an adverse event is zero, nor do they establish that the groups have identical safety profiles. A zero count means that no event of the reported category was recorded among the participants included in that group. The safety denominators differ from the primary endpoint denominators, and the registry does not explain how the safety populations were defined.
Safety figures are descriptive. The record does not report comparative statistical analyses, event-level detail, exposure duration by group, or an explanation of adverse-event collection procedures. The reported absence of events should therefore be read as a statement about recorded events in these groups, not as proof that no adverse events could occur or that the intervention is safer than usual care.
14. What the Result Does, and Does Not, Mean
The posted results describe an observed difference in incident delirium between the analyzed groups, with more recorded cases in the intervention group. The primary risk-difference estimate is positive, and its reported confidence interval does not include zero. This is a statistical description of the registry results; it is not, by itself, proof that the avatar intervention caused the difference.
Randomization can help balance group characteristics, but the registry record does not provide enough information to assess the randomization procedure, participant flow, outcome completeness, or the handling of missing data. The endpoint population is substantially smaller than overall enrollment, and the reason is not reported. These issues limit how confidently the posted estimate can be attributed to the intervention rather than to analysis or measurement processes.
The primary result also does not establish the effect on falls, patient sitter use, or delirium resolution. Although these outcomes are part of the study description or listed outcomes, corresponding numerical results are not reported in the registry record. The available cognitive result does not establish a group difference and cannot be used as a substitute for those unreported outcomes.
Statistical uncertainty remains even when a confidence interval excludes zero. An interval describes uncertainty under a particular calculation and does not account for every source of uncertainty, including possible incomplete screening and differences in site practices. The small number of recorded primary events makes careful attention to the estimate and its interval particularly important.
The results should not be interpreted as medical advice or as a general conclusion about care for hospitalized older adults. They describe one randomized study’s posted outcomes in its analyzed groups. Further interpretation would require fuller reporting of the protocol, analysis plan, participant disposition, missing data, and outcome ascertainment. The registry record does not report those details.
15. Why This Trial Matters Statistically
This trial raises a useful statistical issue: a randomized study can have a much smaller endpoint population than its overall enrollment. The registry reports enrollment of 301, yet the primary endpoint comparison uses 87 intervention participants and 65 controls. The difference is consequential for interpretation because readers need to know who contributed outcome data and why others did not. The registry record does not report that participant flow.
The primary outcome is binary and has few recorded events, including no events in the analyzed control group. Such data highlight why event counts, effect estimates, and uncertainty intervals should be read together. A point estimate can appear clear in direction while remaining sensitive to sparse observations. Reporting the analysis method is especially important in this setting, but the exact primary test and interval method are not reported in the registry record.
The study also illustrates the distinction between a trial’s stated aims and the results available for interpretation. The description includes falls, sitter utilization, delirium, and future algorithm development, but the posted primary endpoint is incident delirium, and numerical results for several broader aims are not reported. A trial may be relevant to multiple research questions, yet each needs outcome-specific data and analysis.
Finally, the cognitive sample-size illustration is based on the observed effect and is explicitly not the trial’s design justification. This distinction matters because retrospective planning illustrations cannot establish whether the study was adequately planned for its actual primary question. The sample-size figures are planning scenarios, not observed power. Clear reporting of a prospective design rationale and analysis plan would be needed to evaluate that question.
16. 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 outcome analysis includes 87 intervention participants and 65 controls, compared with overall enrollment of 301. The registry does not explain the participant flow or the difference in denominators. It also does not report the number of participants randomized to each group, the number missing endpoint assessments, or the reasons for missing assessments. This makes it difficult to assess whether the analyzed groups represent the randomized groups.
Incident delirium depends on repeated CAM screening. The registry describes screening at least daily and a final screen near discharge, but does not report actual screening completeness, missed assessments, assessor training, or procedures for resolving uncertain assessments. The endpoint population requires a final CAM screen on record, so differences in ascertainment could affect who is included and what events are detected.
The registry does not report the detailed statistical analysis plan, the primary test procedure, any covariate adjustment, or sensitivity analyses. It also does not report an adjustment for multiple outcomes. These omissions limit evaluation of prespecification and robustness. The identity of masked parties and the method of maintaining masking are not reported in the registry record.
The study is described as multi-site, but site-specific enrollment, outcome counts, and estimates are not reported. The record therefore does not show whether results were consistent across hospitals or whether site practices influenced screening or care. The intervention’s behavioral and protocol-driven elements may also depend on implementation, but adherence and intervention exposure are not reported.
Several intended outcomes, including falls and sitter utilization, lack numerical results in the registry record, and a quantitative result for delirium resolution is also not reported. The record does not provide enough information to assess the completeness of outcome reporting against the full protocol. These limitations constrain interpretation of both the primary result and the broader study aims.
17. Related Tutorials
18. Related Statistical Calculators
19. Sources
- ClinicalTrials.gov: Care.Coach Avatars for Improvement of Outcomes in Hospitalized Elders, Including Mitigation of Falls and Delirium: a Multi-Site Clinical Study — NCT03832192.
- Registry record last updated 2023-08-14; status last verified 2023-07.
- Results first posted 2023-08-14.
- 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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20. Record Summary
The registry describes a completed Phase 2, randomized, single-masked, parallel-group study of a HELP-protocolized care.coach avatar intervention versus usual care. Overall enrollment was 301. The primary outcome was incident delirium among participants without prevalent delirium who had a final CAM screen on record.
The primary analysis includes 87 intervention participants and 65 controls, with 6 and 0 recorded incident delirium cases, respectively. The reported risk difference is 0.069, with an unadjusted p-value of 0.031. The cognitive-function comparison is posted as a secondary result; quantitative results for delirium resolution, falls, and sitter utilization are not reported in the registry record.
The registry reports no serious adverse events, other adverse events, or deaths in either safety group. Important details about participant flow, missing data, analysis populations, multiplicity, and the statistical analysis plan are not reported in the registry record.