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 Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement? (NCT04850781), a randomized na study. The primary outcome is Time to Nursing Home Placement.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04850781 |
| Phase | NA |
| Condition | Dementia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 243 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Brown University |
| Results posted | Yes |
2. Clinical Question
Population
The trial focused on older adults with Alzheimer’s disease and related dementias (ADRD) connected with Meals on Wheels programs. The project description identifies people on program waiting lists as the intended group for receiving one of the meal models. Specific age limits, dementia severity criteria, and other detailed eligibility requirements are not reported in the registry record.
Intervention
One group received daily home meal delivery. The registry describes a lunchtime meal delivered to participants’ homes multiple times per week, along with a wellness check and socialization. The intervention name and description use different delivery-frequency wording; additional operational detail is not reported in the registry record.
Comparator
The comparison group received frozen, drop-shipped meals: 10 frozen meals mailed to participants every two weeks. Both models are behavioral interventions delivered in the home, but their delivery patterns and accompanying contact differ as described in the registry.
Primary question
The primary question is whether the two meal-delivery models differ in restricted mean time free from nursing home placement, measured through 180 days or death, whichever came first. The posted arm summaries are 172.1 days for Daily Meals and 165.0 days for Frozen, Drop-shipped Meals. A statistical comparison between those summaries is not reported in the registry record, so the posted values alone do not establish whether the observed difference is compatible with chance variation or represents a treatment effect.
3. Trial Design
This was a completed, randomized, double-masked, parallel-group pilot trial. The registry lists an enrollment of 243 and identifies Brown University as the sponsor. The study dates recorded are a start date of 2021-04-12 and a primary completion date of 2022-12-31. The phase is listed as not applicable.
The two behavioral intervention groups were Daily Meals and Frozen, Drop-shipped Meals. Daily Meals were described as lunchtime meals delivered multiple times per week, with a wellness check and socialization. Frozen, Drop-shipped Meals were described as 10 frozen meals mailed every two weeks. Arm sizes recorded with the primary outcome were 128 for Daily Meals and 115 for Frozen, Drop-shipped Meals. The registry record does not report the randomization ratio or explain how the meal delivery schedules were implemented at each site or for each participant.
The brief study description calls this the pilot phase of a pragmatic randomized clinical trial. Its stated purpose included testing procedures for enrolling people with ADRD from Meals on Wheels waiting lists, recruiting a subsample of participants and caregivers for telephone interviews, extracting and transferring program data, and linking participant data with Medicare and nursing home assessment data. Interviews were intended to provide process and mechanistic information about meal experiences and participant outcomes.
The registry’s primary outcome was time to nursing home placement, expressed as restricted mean survival time through 180 days or death. The record lists one outcome measure and no posted secondary outcomes. It lists no statistical analyses. Detailed masking procedures, allocation concealment, recruitment flow, adherence, crossover, and the analysis population are not reported in the registry record.
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: 243 participants were enrolled in the trial.
Overall Study
| Stage | Daily Meals | Frozen, Drop-shipped Meals |
|---|---|---|
| STARTED | 128 | 115 |
| COMPLETED | 128 | 115 |
| NOT COMPLETED | 0 | 0 |
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.
Population: This was an intent-to-treat design; meaning, all participants who were enrolled were analyzed, regardless of how long they received meals.
| Characteristic | Unit | Daily Meals | Frozen, Drop-shipped Meals | Total |
|---|---|---|---|---|
| Participants analysed | 128 | 115 | 243 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 128 | 115 | 243 |
| Sex: Female, Male: Female | Participants | 74 | 78 | 152 |
| Sex: Female, Male: Male | Participants | 54 | 37 | 91 |
| Race/Ethnicity, Customized: Black | Participants | 21 | 22 | 43 |
| Race/Ethnicity, Customized: White | Participants | 64 | 64 | 128 |
| Race/Ethnicity, Customized: Hispanic | Participants | 37 | 25 | 62 |
| Race/Ethnicity, Customized: Other | Participants | 6 | 4 | 10 |
| Lives Alone | Participants | 53 | 66 | 119 |
6. Primary Endpoint
The registry lists the primary outcome as Time to Nursing Home Placement, measured over 6 months / 180 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Days |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is restricted mean survival time for remaining free from nursing home placement, measured up to 180 days or death, whichever came first. It is expressed in days. In general, restricted mean survival time is the area under the event-free survival curve over a prespecified follow-up period. It can be interpreted as the average event-free time accumulated within that period, rather than as a mean time to placement over an unlimited duration.
For this endpoint, nursing home placement is the event of interest, and death ends the period counted as free from placement. Restricting the measure to the stated follow-up horizon makes it possible to summarize event-free time over a defined period without requiring estimates of what happens beyond that period. This can be useful when the question concerns the amount of time participants remain free of an event during a fixed follow-up window.
The posted summaries are means with 95% confidence intervals. Daily Meals has a reported value of 172.1 days, with a 95% confidence interval from 168.9 to 175.3. Frozen, Drop-shipped Meals has a reported value of 165.0 days, with a 95% confidence interval from 161.1 to 169.0. These are arm-level summaries. The registry does not report a confidence interval or test for the contrast between the arms, nor does it describe how censoring or other incomplete follow-up was handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports restricted mean time free from nursing home placement of 172.1 days for Daily Meals, with a 95% confidence interval from 168.9 to 175.3, and 165.0 days for Frozen, Drop-shipped Meals, with a 95% confidence interval from 161.1 to 169.0. Both values concern time accumulated within the stated limit of 180 days or death, whichever came first. They should not be read as unrestricted average times until nursing home placement.
The confidence intervals describe uncertainty around each arm’s estimated mean, under the analysis used to produce the estimates. In general, a confidence interval represents a range of values compatible with the data and the statistical procedure at the stated confidence level. It does not give the probability that an individual participant will remain at home for a particular number of days. The registry record does not provide the method used to construct these intervals.
The arm summaries are not themselves a formal comparison. Although the numerical estimates differ, the record does not post an estimated between-arm contrast, its confidence interval, or a hypothesis-test result. Without those, the precision of the difference cannot be assessed directly from the registry report. The record also does not report adjustment variables or an analysis plan that would clarify whether the arm summaries are adjusted or unadjusted.
The trial is described as a pilot, and the project summary emphasizes testing procedures as well as learning about participant and caregiver experiences. The registry does not report a sample-size justification or state that the trial was designed to detect a particular difference in the primary endpoint. The arm values therefore describe the posted pilot results; they should not be treated as definitive evidence about the comparative effect of the meal models.
Interpretation is further limited by the absence of reported secondary outcomes, analysis details, and information about missing observations or the analysis population. Deaths are listed separately in the adverse-event information, but the registry does not give their timing or explain their individual contribution to the primary endpoint. The posted results are informative as descriptive summaries, while the absence of a reported comparison leaves the central treatment contrast statistically unresolved.
9. Statistical Methods Explained
The record identifies a randomized, double-masked, parallel-group design. In general, randomization aims to make treatment groups comparable at the start of a trial with respect to both measured and unmeasured characteristics, on average. It does not guarantee exact balance in any particular trial. The registry does not report the sequence-generation or allocation-concealment methods. Double masking means the record labels the study as masked at two levels, but it does not identify which people were masked or how masking was maintained. Details are not reported in the registry record.
What does the primary summary represent?
The endpoint is restricted mean survival time through 180 days or death, whichever came first. In general, survival analysis methods describe time until an event and account for the fact that some participants may not experience the event during observed follow-up. Restricted mean survival time summarizes the average event-free time within a fixed horizon. Here the event is nursing home placement; death is specified as the point at which the restricted follow-up ends. The registry reports the outcome in days, but does not give the calculation procedure, handling of censoring, or individual follow-up information.
The reported values are arm-specific means with 95% confidence intervals. A confidence interval communicates uncertainty in an estimate under the assumptions of its statistical method. Its width depends on features such as the amount and variability of the data and the method used. The registry does not specify the confidence-interval method or report a standard error or dispersion measure. The posted intervals therefore provide a precision summary, but the precise estimation procedure cannot be checked from the record.
How should the two arms be compared?
For a comparative question, the central estimate would ordinarily be a contrast between the arm-level restricted means, accompanied by uncertainty and, where relevant, a test result. The record lists no statistical analyses and does not post a contrast, confidence interval for a contrast, or p-value. The arm summaries should therefore be read separately rather than treated as a complete inferential comparison. No adjusted or unadjusted comparison is reported in the registry record.
In general, an interval around each arm mean is not a substitute for an interval around the difference between arms. The uncertainty of a contrast depends on the joint statistical comparison, including the variation and dependence structure used in the analysis. No new contrast can be inferred reliably from the posted arm-level confidence intervals alone. There is also no reported specification of covariates, stratification factors, or other model terms.
What role do sample-size illustrations play?
Any sample-size illustrations based on an observed effect are planning calculations, not observed trial outcomes and not evidence of the trial’s power after completion. In general, such calculations ask how many participants per arm might be needed for a chosen target power under stated assumptions. The record’s planning assumptions describe a two-sided significance level of 0.05, equal allocation, a normal approximation, and detection of a stated fraction of the observed effect. They are explicitly planning assumptions, not a description of the trial’s actual allocation or original design justification. The registry does not report the original sample-size rationale or a target effect used to design the trial.
Sample-size calculations based on an observed pilot estimate can be sensitive to uncertainty in that estimate. If the observed effect is imprecise, a planning calculation that treats it as fixed can convey more certainty than the data warrant. In general, pilot results are often useful for assessing feasibility and refining procedures, while estimates of treatment effects may remain uncertain. No numeric planning result or original power calculation is reported in the registry record.
Why can event-time methods be useful?
In general, event-time methods are appropriate when the outcome includes both whether an event occurred and when it occurred. A simple count of placements would omit timing; a restricted mean summarizes event-free time within the defined horizon. The endpoint also stops counting at death. That specification makes death relevant to the estimand, but the record does not provide further detail on how the estimator incorporated deaths, incomplete observation, or any competing-event framework. No additional analytic assumptions should be inferred from the endpoint label alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and no posted secondary outcomes. It does not report a multiplicity strategy, such as whether any adjustments were planned for multiple outcomes or multiple analyses. With no listed secondary outcomes and no analyses posted, the registry record does not allow assessment of how multiplicity was addressed in the broader study work.
Missing-data methods are not reported in the registry record. There is no description of the amount or pattern of missing primary-outcome data, loss to follow-up, censoring rules, imputation, or sensitivity analyses. These details matter because estimates of time to an event can depend on how follow-up ends and on assumptions about participants whose outcomes are not fully observed. The endpoint description states that measurement is restricted to 180 days or death, but does not explain how administrative end of follow-up or other incomplete observations were treated.
The analysis population is also not reported in the registry record. The arm sizes accompanying the outcome are 128 for Daily Meals and 115 for Frozen, Drop-shipped Meals, but those values alone do not establish whether all randomized participants were included in the primary analysis or how deviations from assigned delivery were handled. The registry does not describe intention-to-treat, per-protocol, or other analysis populations.
There is no reported statistical analysis plan, and the record lists 0 analyses. The posted arm-level outcomes remain interpretable as reported summaries, but readers cannot determine from the registry record whether prespecified methods, exclusions, or missing-data procedures shaped them.
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 |
|---|---|---|---|
| Daily Meals | 0 | 128 | 0.0% |
| Frozen, Drop-shipped Meals | 0 | 115 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Daily Meals | 5 of 128 |
| Frozen, Drop-shipped Meals | 8 of 115 |
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 |
|---|---|
| Daily Meals | 0 of 128 |
| Frozen, Drop-shipped Meals | 0 of 115 |
The registry lists 0 serious adverse events and 0 other adverse events for Daily Meals, among 128 at risk in each category. For Frozen, Drop-shipped Meals, it lists 0 serious adverse events and 0 other adverse events, among 115 at risk in each category. Deaths are listed separately: 5 for Daily Meals and 8 for Frozen, Drop-shipped Meals. These counts should be read as the registry reports them, without treating the deaths as included in either adverse-event count.
These entries are counts, not comparative risk estimates. The registry does not report event descriptions, timing, causes of death, attribution to an intervention, or details about the process used to collect adverse events. It also does not report whether every participant had the same duration of safety follow-up. The absence of listed adverse events should therefore be understood as the posted registry figures, not as proof that no untoward events occurred in any broader sense.
Death also matters to the primary endpoint because the restricted mean is defined up to 180 days or death, whichever came first. The record does not explain how the individual deaths related to nursing home placement or the endpoint analysis. The separate safety counts cannot establish that relationship.
12. What the Result Does, and Does Not, Mean
The posted results describe two arm-level estimates for restricted mean time free from nursing home placement through 180 days or death. Daily Meals is reported at 172.1 days, with a 95% confidence interval from 168.9 to 175.3. Frozen, Drop-shipped Meals is reported at 165.0 days, with a 95% confidence interval from 161.1 to 169.0. The outcome is about average event-free time within the defined follow-up horizon, not the time until placement for every participant.
These results do not, on their own, establish that one meal model caused a longer period without nursing home placement. The registry does not report a formal between-arm estimate, confidence interval, or statistical test. Nor does it report enough analysis detail to assess adjustments, missing data, censoring, or the population included in the analysis. The arm estimates should consequently be treated as descriptive posted results rather than a complete causal comparison.
The pilot context is important. The project summary describes work on enrollment procedures, interviews, data transfer, and linkage with Medicare and nursing home assessment data, as well as participant outcomes. This design can generate information about feasibility and study processes, but the registry does not report a sample-size justification or state that the trial was powered for a particular clinical difference. Any planning illustrations based on an observed estimate are not observed power and do not show that the trial could reliably detect a specified effect.
The registry also gives adverse-event counts and deaths, but not event timing, causes, attribution, or follow-up detail. Those entries provide limited safety description and do not resolve how deaths were handled in the primary analysis. Overall, the record supports a precise description of the reported arm summaries and their stated confidence intervals, but not a definitive conclusion about comparative effectiveness or safety.
13. Why This Trial Matters Statistically
This trial raises a statistical question that is easy to overlook: the outcome is not simply whether nursing home placement occurred. It is the average time free from placement over a defined period, with follow-up ending at 180 days or death. Restricted mean survival time expresses that time-based question in days and can summarize event-free experience within the chosen horizon without interpreting an unrestricted time-to-event average.
The comparison also illustrates why arm-level results and treatment contrasts are different quantities. A mean and confidence interval for each group describe each group separately. They do not supply the estimated difference and its uncertainty. The registry reports the arm summaries but no comparative analysis, so the central question in the trial title is not answered statistically by the posted endpoint estimates alone.
The pilot purpose adds another important distinction. A trial can test recruitment, interview, data-transfer, and linkage procedures while also reporting clinical outcomes. Those operational aims can be valuable, but they do not by themselves establish that the sample size or analysis was designed for a definitive comparison. The registry does not report the original sample-size rationale, so the evidential role of the outcome estimates should remain bounded by what is documented.
Finally, death is built into the endpoint definition and is also reported separately in the safety information. That makes clear reporting of the estimand, censoring, follow-up, and analysis population especially useful. The registry record does not provide those details. The trial is therefore a useful example of why transparent reporting of the outcome definition and the comparative analysis is necessary for readers to distinguish a descriptive pattern from an inferential conclusion.
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 registry record provides limited detail for evaluating how the study was conducted and how the primary endpoint was analyzed. It does not report participant characteristics beyond the focus on older adults with ADRD, nor does it give detailed eligibility criteria, recruitment flow, site information, or baseline comparability. These omissions constrain assessment of how broadly the results may apply.
The intervention descriptions give different levels of detail. Daily Meals is described as a lunchtime meal delivered multiple times per week with a wellness check and socialization, while Frozen, Drop-shipped Meals is described as 10 frozen meals mailed every two weeks. The registry does not explain whether delivery schedules varied, how adherence was assessed, or how deviations and crossovers were handled. Masking is recorded as double, but the people masked and the procedures are not described.
For the primary outcome, the record gives arm estimates and confidence intervals but no comparative estimate or analysis method. Censoring, missing data, deaths’ relationship to placement, analysis population, and adjustment variables are not reported. There are no posted secondary outcomes and no analyses listed. The record also does not give the original sample-size justification or a prespecified statistical analysis plan.
Safety information is limited to counts of serious adverse events, other adverse events, and deaths. Event types, timing, attribution, and ascertainment procedures are not reported. Together, these gaps mean that readers can describe the posted results but cannot fully evaluate the robustness of the primary comparison, the completeness of follow-up, or the interpretation of the safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Home-delivered Meals for Persons With Dementia: Which Model Delays Nursing Home Placement? — NCT04850781.
- Registry record last updated 2024-01-03; status last verified 2023-12.
- Results first posted 2024-01-03.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry identifies a completed, randomized, double-masked, parallel-group pilot trial sponsored by Brown University. It enrolled 243 and compared Daily Meals with Frozen, Drop-shipped Meals among people with dementia. The primary outcome was restricted mean time free from nursing home placement through 180 days or death, whichever came first.
The reported arm summaries are 172.1 days for Daily Meals, with a 95% confidence interval from 168.9 to 175.3, and 165.0 days for Frozen, Drop-shipped Meals, with a 95% confidence interval from 161.1 to 169.0. The registry lists no secondary outcomes and no statistical analyses. It does not report a between-arm estimate or sufficient analysis details to assess the comparative result.
Serious and other adverse-event counts are listed as 0 in both arms; deaths are listed separately as 5 for Daily Meals and 8 for Frozen, Drop-shipped Meals. Additional safety and follow-up details are not reported in the registry record.