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 Enhanced Quality in Primary Care for Elders With Diabetes and Dementia (NCT03723707), a randomized na study. The primary outcome is Percent of Patients Who Reach Consensus Target HBA1c.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03723707 |
| Phase | NA |
| Condition | Diabetes, Dementia, Alzheimer Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 355 |
| Arms in the primary outcome | 2 |
| Lead sponsor | NYU Langone Health |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerns people with diabetes and dementia, including Alzheimer disease, receiving primary care. Its primary outcome description focuses on patients who completed the 24-month follow-up and had an HbA1c value reported in the electronic health record within 6 months of study completion. The posted record does not give a more detailed description of the population included in the outcome analysis.
Intervention
The intervention was a care-quality improvement program called EQUIPED-ADRD. Its components included clinician practice guidelines and education, electronic health record support, information about community and clinical resources, targeted feedback to providers, and panel-manager support for workflow. The study’s brief description also refers to consensus decision guidance and collaborative learning for primary-care providers.
Comparator
The control group received training that encouraged providers to conduct cognitive screening and follow guidelines generally. The registry record describes both study arms as behavioral interventions. It does not give further detail about the control providers’ usual clinical practices or the extent to which those practices differed across sites.
Primary question
The primary question was whether the percentage of patients reaching the consensus HbA1c target differed between the intervention and control groups by the end of the trial. The target was described as HbA1c from 7 through 8.5. The posted outcome gives a percentage and a 95% confidence interval for each arm, but no between-group estimate or analysis is posted. The arm summaries therefore describe the observed results without establishing the size or statistical uncertainty of a group difference.
3. Trial Design
This was a randomized, single-masked, parallel-group study of a behavioral care-quality improvement intervention. The registry lists an enrollment of 355 and identifies diabetes, dementia, and Alzheimer disease as conditions of interest. The trial is marked completed. Its recorded start date is 2018-12-03, and its primary completion date is 2022-10-20. The phase is listed as NA.
The intervention arm was EQUIPED-ADRD. The described components included clinician guidelines and education, electronic health record support for diabetes and dementia care, information about resources, targeted provider feedback, and panel-manager support. The control arm’s training encouraged cognitive screening and general guideline use. Both arms are categorized as behavioral interventions.
The primary outcome is a continuous measure summarized as a mean, with a 95% confidence interval. The outcome itself is a percentage: the percentage of patients with HbA1c in the consensus target range at the end of the trial. The outcome description limits this to participants completing the 24-month follow-up who had an electronic health record value within 6 months of study completion. The posted endpoint results include 25 participants in the intervention arm and 32 in the control arm. The record does not explain why these outcome denominators are smaller than total enrollment.
Random allocation and single masking are recorded, but the identity of the masked parties and the allocation procedure are not reported in the registry record. The record also does not report further operational detail about site-level allocation, adherence, or intervention delivery. These omissions limit how fully the design can be reconstructed from the registration and posted results alone.
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 (INT) | Control (CON) |
|---|---|---|
| STARTED | 191 | 164 |
| COMPLETED | 68 | 78 |
| NOT COMPLETED | 123 | 86 |
Reasons for not completing this period:
| Reason | Intervention (INT) | Control (CON) |
|---|---|---|
| Death | 32 | 32 |
| Admitted to long term care | 12 | 12 |
| No longer receiving care at NYU Langone Health | 15 | 8 |
| Lost to Follow-up | 40 | 22 |
| Discontinued after study closure | 24 | 12 |
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 (INT) | Control (CON) | Total |
|---|---|---|---|---|
| Participants analysed | 68 | 78 | 146 | |
| Age, Continuous | years | 79.5 (SD 7.21) | 79 (SD 7.37) | 79 (SD 7.27) |
| Sex: Female, Male: Female | Participants | 38 | 49 | 87 |
| Sex: Female, Male: Male | Participants | 30 | 29 | 59 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 24 | 29 | 53 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 44 | 49 | 93 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 6 | 6 | 12 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 13 | 14 | 27 |
| Race (NIH/OMB): White | Participants | 48 | 58 | 106 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 68 | 78 | 146 |
6. Primary Endpoint
The registry lists the primary outcome as Percent of Patients Who Reach Consensus Target HBA1c, measured over Up to Month 24.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the percentage of patients reaching the consensus HbA1c target by the end of the trial. The target range is described as HbA1c at least 7 and at most 8.5. The endpoint applies to patients who completed the 24-month follow-up and had a reported electronic health record value within 6 months of study completion. The registry gives the timeframe as up to Month 24.
This outcome expresses the share of eligible patients whose recorded HbA1c falls within a consensus range, rather than reporting an average HbA1c concentration or a change from baseline. A proportion can be useful for describing how often a defined care target is reached across a group. In this trial, it links the intervention’s quality-improvement focus to a recorded clinical measure. The registry does not report the rationale for selecting this endpoint or the consensus process that established the target.
The intervention-arm estimate is 12.0%, with a 95% confidence interval from -1.3 to 25.3. The control-arm estimate is 18.75%, with a 95% confidence interval from 4.7 to 32.8. These are arm-specific summaries. A between-group estimate and its uncertainty are not posted, so the endpoint summaries do not themselves quantify the comparative effect of assignment to the intervention.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome estimates are 12.0% in the intervention arm and 18.75% in the control arm. The corresponding 95% confidence intervals are -1.3 to 25.3 for intervention and 4.7 to 32.8 for control. These figures describe the outcome as recorded for the participants contributing to each arm’s endpoint summary; they do not describe all 355 enrolled participants unless the record says so, and it does not.
A confidence interval conveys uncertainty around an estimate under the assumptions of the method used to calculate it. In general, a wider interval indicates less precision than a narrower interval. Both intervals span a substantial range of possible values, so the arm-level percentages are not precise estimates of the underlying percentages in the populations represented by the trial. The intervention interval also extends below zero, even though the endpoint is a percentage. The record does not explain the interval calculation or whether a method constrained estimates to the possible range for a percentage.
The registry record does not post a between-arm comparison, a test statistic, or a p-value for this endpoint. The arm estimates and their separate confidence intervals are not substitutes for a confidence interval around the difference between groups. A direct comparison would account for uncertainty in both arms and would estimate the contrast of interest. Without that result, the posted outcome does not establish whether the groups differ statistically, nor does it provide a precise estimate of the intervention’s comparative effect.
The outcome denominators are 25 for intervention and 32 for control, while recorded enrollment is 355. The record does not state why only these participants appear in the primary outcome summaries. The endpoint description specifies completion of the 24-month follow-up and an HbA1c value in the electronic health record within 6 months of study completion, but it does not report how many participants met those conditions in each arm or how missing values were handled. The difference between overall enrollment and endpoint denominators therefore raises an important interpretive limitation without identifying its cause.
Accordingly, the posted results support a descriptive reading of each arm’s recorded target percentage and its uncertainty. They do not support a definitive conclusion about the comparative effect, and they do not show why the observed arm summaries differ. The sponsor’s own analysis is not displaced by recalculations: no recalculated two-arm comparison is available in this record.
9. Statistical Methods Explained
What does the endpoint estimate represent?
The endpoint is a percentage of patients whose HbA1c falls within the stated consensus range. The registry labels the measure as a mean and reports a 95% confidence interval for each arm. For a percentage outcome, the mean corresponds to the observed proportion expressed as a percentage. The posted summaries are 12.0% for intervention and 18.75% for control. The associated outcome denominators are 25 and 32, respectively.
The denominator matters because the percentage describes the participants represented in that arm’s outcome data. Total trial enrollment was 355, but the record does not explain the smaller denominators in the posted primary results. The endpoint description refers to completed follow-up and an electronic health record HbA1c value within 6 months of study completion. It does not say how many enrolled participants lacked a value, failed to complete follow-up, or were excluded for another reason.
How should the confidence intervals be read?
A confidence interval is an uncertainty range around an estimate, calculated using a statistical procedure and assumptions. In general, it indicates how compatible a range of values is with the observed data and that procedure; it is not a guarantee that the true value lies within the interval. The posted 95% confidence intervals are -1.3 to 25.3 for intervention and 4.7 to 32.8 for control. Their breadth indicates that the arm-specific estimates are imprecise. The interval for the intervention percentage includes values below zero, although a percentage itself cannot be negative. The registry does not report the interval method or explain this feature.
Separate confidence intervals for two arms do not provide the confidence interval for their difference. A comparative analysis would estimate an arm contrast and its uncertainty directly. The registry record does not post that estimate or an inferential test for the primary outcome. It is therefore not appropriate to infer a formal between-arm result just by comparing the two point estimates or visually judging overlap between separate intervals.
Why can a direct comparison be unavailable?
A direct comparison requires a specified analysis of the outcome across randomized groups. The posted information gives arm-level summaries but says that values are missing or not estimable for a two-arm comparison of this continuous endpoint. The registry record does not explain why a comparison could not be estimated, whether a particular model was attempted, or what assumptions were considered. Without an estimate and uncertainty for the contrast, the arm summaries remain descriptive rather than a complete comparative analysis.
What does randomization contribute?
Random allocation is recorded as a design feature. In general, randomization aims to make treatment groups comparable with respect to both measured and unmeasured characteristics at the point of allocation, on average. It does not ensure that the groups will be identical, and its value for interpretation depends on preserving the assigned groups and analyzing outcomes appropriately. The record does not report the allocation sequence method, concealment procedures, or a detailed analysis population. Single masking is also recorded, but which people were masked is not reported in the registry record.
What can be said about precision and planning?
The outcome denominators are small relative to total enrollment, and the arm-specific confidence intervals are broad. As a general statistical principle, fewer observed outcomes can yield less precise estimates, although precision also depends on the data and method. No trial-specific sample-size justification is reported in the registry record. The record does not report interim analyses or a detailed statistical analysis plan. Any planning illustration based on an observed effect would be a hypothetical design calculation, not evidence of the trial’s original design or of observed power.
The posted endpoint summaries do not include a measure of spread such as a standard deviation because the outcome is reported as a percentage with confidence intervals. The exact confidence-interval procedure, any adjustment for the trial’s design, and any treatment of clustering or site effects are not reported. Those details can matter for uncertainty estimates in a multi-site care-quality intervention, but their use cannot be assumed from the information recorded.
Why does the endpoint definition matter?
The outcome definition includes both a target range and requirements for follow-up and electronic-record data. Results therefore depend on how those conditions were applied and on which participants had qualifying values. General statistical interpretation of a proportion assumes a clearly defined numerator and denominator. Here, the endpoint description identifies the intended measure, but the record does not explain the participant flow or missing-data procedures that connect total enrollment to the analyzed denominators. That limits assessment of selection and missing-data risks.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure and no posted secondary outcomes. It records zero analyses. This does not establish whether additional analyses were planned or conducted outside the posted record. The analysis plan, any prespecified subgroups, and any interim analyses are not reported in the registry record. Because the number and hierarchy of planned analyses are not documented, the handling of multiplicity cannot be assessed.
Missing-data information is also limited. The endpoint definition requires completion of the 24-month follow-up and an electronic health record HbA1c value within 6 months of study completion. The outcome summaries use 25 intervention participants and 32 control participants, whereas enrollment is 355. The registry does not report participant flow by arm, reasons for unavailable endpoint data, imputation methods, or sensitivity analyses. It also does not specify a primary analysis population, such as all randomized participants or only those with observed endpoint values.
These omissions matter because an observed-data percentage may represent a selected subset if participants without qualifying measurements differ from those with measurements. This is a general concern, not evidence that such selection occurred. Without a description of missingness and analysis populations, readers cannot determine how the posted arm estimates relate to all randomized participants or how robust they are to missing outcome data.
The record does not report whether covariate adjustment or site-level features were included in the analysis. It also does not provide a detailed model or inferential procedure for the primary outcome. These statistical-plan details are not reported in the registry record, so the posted arm summaries cannot be linked to a fully specified analysis strategy.
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 |
|---|---|---|---|
| Intervention (INT) | 69 | 191 | 36.1% |
| Control (CON) | 65 | 164 | 39.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention (INT) | 33 of 191 |
| Control (CON) | 32 of 164 |
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 (INT) | 0 of 191 |
| Control (CON) | 0 of 164 |
Most frequent serious adverse event terms
| Event term | Organ system | Intervention (INT) | Control (CON) |
|---|---|---|---|
| Death NOS | General disorders | 28 of 191 | 20 of 164 |
| Fall | Injury, poisoning and procedural complications | 20 of 191 | 11 of 164 |
| Upper respiratory infection | Infections and infestations | 8 of 191 | 4 of 164 |
| Syncope | Nervous system disorders | 6 of 191 | 3 of 164 |
| Abdominal pain | Gastrointestinal disorders | 2 of 191 | 5 of 164 |
| Heart Failure | Cardiac disorders | 2 of 191 | 5 of 164 |
| Hyperglycemia | Metabolism and nutrition disorders | 2 of 191 | 5 of 164 |
| Lung Infection | Infections and infestations | 4 of 191 | 1 of 164 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 4 of 191 | 1 of 164 |
| Urinary tract infection | Infections and infestations | 0 of 191 | 5 of 164 |
Serious events with the highest arm-level rate: death nos (14.7%), fall (10.5%), upper respiratory infection (4.2%), syncope (3.1%), abdominal pain (3.0%).
The serious adverse event summaries list 191 participants at risk in the intervention group, with 69 affected, and 164 at risk in the control group, with 65 affected. Deaths are listed as 33 in intervention and 32 in control. The record also lists zero other adverse events in each group. These are registry counts and should be read as descriptive safety information, not as a causal comparison.
The record does not provide a comparative statistical analysis of adverse events, nor does it state whether the death counts overlap with the serious adverse event counts. The counts should therefore not be added together or treated as independent categories. The listed top serious adverse event terms and percentages are Death NOS, 14.7%; Fall, 10.5%; Upper respiratory infection, 4.2%; Syncope, 3.1%; Abdominal pain, 3.0%; and Heart Failure, 3.0%. The record does not give arm-specific percentages for these terms in the posted summary.
In general, adverse-event counts alone do not establish that an event was caused by an intervention. Interpretation also depends on definitions, observation periods, participant exposure, and how events were collected and classified. Further detail about these aspects is not reported in the registry record. These figures describe what is posted and do not independently demonstrate a difference in safety between the groups.
12. What the Result Does, and Does Not, Mean
The primary outcome results describe the percentages of participants with a recorded HbA1c in the consensus target range among those contributing to each arm’s posted endpoint summary. The intervention estimate is 12.0%, and the control estimate is 18.75%. Their confidence intervals are broad, and the registry provides no direct estimate of the difference between groups. The results therefore communicate arm-level observations, not a definitive comparative effect.
The trial tested a multi-component quality-improvement approach in primary care, rather than an isolated clinical treatment. Its intervention description includes guidelines, provider education, electronic health record support, resource information, provider feedback, and panel-manager workflow support. The control training also encouraged cognitive screening and general guideline use. The posted endpoint alone cannot identify which intervention component, if any, contributed to the observed outcome.
These results do not establish whether the intervention changed the probability of reaching the HbA1c target compared with control. They also do not show that the target itself is appropriate for every individual, or that reaching the target guarantees a particular clinical outcome. The endpoint is a registry-defined measure of target attainment, and the record does not report additional patient outcomes that could broaden its interpretation.
The large gap between total enrollment and the outcome denominators is important, but its cause is unknown from the registry record. The posted percentages should not be treated as estimates for all enrolled participants without further information about eligibility, follow-up, missing measurements, and analysis populations. Nor should the adverse-event counts be used to infer causation or a comparative safety effect without further analyses.
Overall, the registry supports a cautious description of the trial design, endpoint, arm-specific results, and posted safety counts. It does not supply the comparative statistical analysis or missing-data details needed for a complete assessment of the primary question. Those limits should remain central when interpreting the outcome.
13. Why This Trial Matters Statistically
This trial addresses a practical statistical challenge: evaluating a multi-part quality-improvement program when the primary outcome depends on follow-up and routine electronic health record data. The registry defines target attainment among patients completing the 24-month follow-up and with a qualifying record value. This makes the endpoint closely tied to both clinical measurement and the availability of routine-care data.
The distinction between total enrollment and endpoint denominators is particularly important for readers of clinical trials. A randomized design can support a fair comparison, but interpretation still depends on how outcomes are obtained and analyzed after allocation. Here, enrollment is 355, while the primary summaries include 25 intervention participants and 32 control participants. The record does not explain that difference. A transparent participant flow and missing-data account would help readers understand the scope of the endpoint estimates.
The trial also illustrates why arm-specific estimates should not be mistaken for a treatment contrast. The intervention and control percentages have separate confidence intervals, but no comparative estimate is posted. A formal contrast is needed to answer the randomized trial’s primary comparative question and to express the precision of that comparison.
Finally, the intervention is a package of practice supports, not a single component. Even with a clear comparative result, attribution to particular parts of the package would require additional evidence or analyses. The posted record is therefore useful for understanding the intended care model and the limits of the available outcome reporting, while underscoring the importance of complete analysis and reporting for complex implementation trials.
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 posted primary outcome has modest arm-specific denominators: 25 in intervention and 32 in control, compared with enrollment of 355. The registry record does not explain the participant flow leading to those denominators, the reasons for absent outcomes, or the analysis population. This limits assessment of whether the percentages represent all randomized participants or a subset with complete follow-up and electronic health record data.
No between-arm estimate, confidence interval for the contrast, or p-value is posted for the primary endpoint. The separate arm-level estimates cannot replace a comparative analysis. The registry also does not report the statistical method used to calculate the confidence intervals, despite the intervention interval extending below zero for a percentage outcome.
Important design and analysis details are not reported in the registry record, including who was masked, allocation procedures, any adjustment for site or other characteristics, the missing-data approach, and a detailed statistical analysis plan. The registry lists one primary outcome, zero secondary outcomes, and zero analyses, but this does not resolve what analyses may have been planned or conducted elsewhere. Interim analyses and sample-size justification are not reported.
The intervention includes multiple components, so the primary endpoint cannot isolate the contribution of any one element. The control description is brief, and details about clinical practice, adherence, implementation, or differences among sites are not reported. These limitations make the posted results informative as descriptive registry findings but incomplete for assessing comparative effectiveness, precision, and possible sources of bias.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Enhanced Quality in Primary Care for Elders With Diabetes and Dementia — NCT03723707.
- Registry record last updated 2023-11-09; status last verified 2023-11.
- Results first posted 2023-11-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03723707, titled “Enhanced Quality in Primary Care for Elders With Diabetes and Dementia,” is recorded as a completed, randomized, single-masked, parallel-group behavioral study. It lists enrollment of 355, with a start date of 2018-12-03 and primary completion date of 2022-10-20. The intervention combined clinician guidance and education, electronic health record support, resource information, provider feedback, and panel-manager workflow support. Control training encouraged cognitive screening and general guideline use.
The primary outcome was the percentage of patients reaching the consensus HbA1c target by up to Month 24, based on follow-up completion and an electronic health record value within 6 months of study completion. The intervention estimate was 12.0% (95% confidence interval -1.3 to 25.3); the control estimate was 18.75% (95% confidence interval 4.7 to 32.8). The registry does not post a direct comparison or explain the smaller outcome denominators. Serious adverse event counts and selected event terms are also listed, without a comparative analysis.