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 Improving Aging in Place in Subsidized Housing (NCT04212442), a randomized na study. The primary outcome is Change in Precipitating Events Project (PEP) Functional Status Scale From Baseline to 2 Months for Immediate Intervention Sites and Waitlist Control Sites.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04212442 |
| Phase | NA |
| Condition | Physical Disability, Cognitive Impairment, Physical Activity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 75 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Pennsylvania |
| Results posted | Yes |
2. Clinical Question
Population
Older adults living in subsidized housing, including participants with and without mild cognitive impairment or mild dementia. The registry record does not report a specific age range in the listed study description.
Intervention
The Independent Living Program for Affordable Housing, an adapted telephone-based version of Function Focused Care. Participants assigned to the immediate intervention received it for two consecutive months after enrollment.
Comparator
A wait-list control group. Participants in this group received the same adapted telephone-based intervention for two consecutive months, starting two months after enrollment.
Primary question
Did the mean change from baseline to 2 months in self-reported functional status differ between the immediate intervention and wait-list control groups? The primary measure was the Precipitating Events Project Functional Status Scale, on which higher scores indicate more functional impairment.
3. Trial Design
This completed pilot study evaluated the feasibility and preliminary effectiveness of an adapted, telephone-delivered Function Focused Care intervention for older adults living in subsidized housing. The registry record lists randomized allocation, a parallel-group design, and no masking. The sponsor was the University of Pennsylvania. The listed enrollment was 75; that figure is not the number analyzed for every outcome.
Participants assigned to the Immediate Intervention received the Independent Living Program for Affordable Housing for two consecutive months upon enrollment. Participants assigned to the Wait-list Control received the program for two consecutive months beginning two months after enrollment. The primary outcome timeframe was baseline and 2 months, so the comparison concerns changes during the period when the immediate group had access to the program and the wait-list group had not yet started it.
The study included participants with and without mild cognitive impairment or mild dementia. The study description says it would examine whether outcomes differed by cognitive status, but results for such comparisons are not reported in the registry record. The record lists a start date of 2020-01-13, a primary completion date of 2023-01-24, and a completed status. Phase is listed as NA.
The primary outcome results include 28 participants in the Immediate Intervention group and 13 in the Wait-list Control group. The registry notes that loss to follow-up for self-reported outcomes means the overall number analyzed does not match participant-flow figures. The reasons for the differences between outcome counts and participant-flow figures, and the analysis procedures used to address missing outcomes, 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.
Overall Study
| Stage | Immediate Intervention | Wait-list Control |
|---|---|---|
| STARTED | 47 | 28 |
| COMPLETED | 42 | 23 |
| NOT COMPLETED | 5 | 5 |
Analysis population for the primary outcome, as defined in the registry: Please note that due to loss to follow-up for self-reported outcome measures, the overall number of participants analyzed is not consistent with numbers provided in the rows in the participant flow module.
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 | Immediate Intervention | Wait-list Control | Total |
|---|---|---|---|---|
| Participants analysed | 47 | 28 | 75 | |
| Age, Continuous | years | 72.5 (SD 7.9) | 72.3 (SD 7.0) | 72.4 (SD 7.5) |
| Sex: Female, Male: Female | Participants | 42 | 18 | 60 |
| Sex: Female, Male: Male | Participants | 5 | 10 | 15 |
| Race/Ethnicity, Customized: White, non-Hispanic | Participants | 30 | 2 | 32 |
| Race/Ethnicity, Customized: Black, non-Hispanic | Participants | 13 | 11 | 24 |
| Race/Ethnicity, Customized: Hispanic/Latino | Participants | 4 | 13 | 17 |
| Race/Ethnicity, Customized: Other (individuals who self-identified as American Indian or Alaska Native, Asian, or other race) | Participants | 0 | 2 | 2 |
| Region of Enrollment: United States | Participants | 47 | 28 | 75 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Precipitating Events Project (PEP) Functional Status Scale From Baseline to 2 Months for Immediate Intervention Sites and Waitlist Control Sites, measured over Baseline, 2 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline to 2 months in the Precipitating Events Project (PEP) Functional Status Scale. It is a self-reported measure of ability to perform 7 activities of daily living, 5 instrumental activities of daily living, and 3 mobility tasks. Scores range from 0-30, with higher scores indicating more functional impairment.
Function is closely related to the study’s focus on aging in place: difficulty with daily activities and mobility can describe how independently a person manages routine tasks. The scale therefore measures a functional outcome that is directly relevant to the intervention’s stated aim of supporting function among older adults in subsidized housing. The endpoint is a change score, so the comparison is between the groups’ mean changes over the same baseline-to-2-month period, rather than a comparison of their scores at a single time alone.
Because the scale is self-reported, its results reflect participants’ reports of their own abilities. The registry record notes loss to follow-up for self-reported measures but does not report details of how missing scale responses were handled. The scale’s range and direction help interpret the mean changes: a negative change indicates movement toward lower reported impairment, while a positive change indicates movement toward higher reported impairment. This description concerns the measure’s scoring direction, not a clinical judgment about an individual participant.
7. Results Posted in the Registry
- Immediate Intervention: mean -1.30 versus 0.60 on control; difference -1.90 (95% CI -3.45 to -0.35), standardized effect d = -0.94; z-test p = 0.016.
Mean difference: Immediate Intervention
95% CI: -3.45 to -0.35
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 EuroQol 5 Dimensions (EQ-5D-5L) Scale From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites | Continuous Endpoint | Mean difference | 0.14 (-0.07 to 0.35) | 69 per arm |
| Change in Geriatric Depression Scale Short Form (GDS Short Form) Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites | Continuous Endpoint | Mean difference | -1.68 (-2.66 to -0.70) | 26 per arm |
| Change in Number of Hospitalizations During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites) | Continuous Endpoint | Mean difference | -0.10 (-0.37 to 0.17) | 443 per arm |
Change in EuroQol 5 Dimensions (EQ-5D-5L) Scale From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
- 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:
- Immediate Intervention: mean 0.09 versus -0.05 on control; difference 0.14 (95% CI -0.07 to 0.35), standardized effect d = 0.48; z-test p = 0.192.
- Interpretation:
- The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Immediate Intervention and the control. The interval gives the range of effects that remain compatible with the data.
Change in Geriatric Depression Scale Short Form (GDS Short Form) Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
- 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:
- Immediate Intervention: mean -1.26 versus 0.42 on control; difference -1.68 (95% CI -2.66 to -0.70), standardized effect d = -0.78; z-test p = <0.001.
- Interpretation:
- The 95% confidence interval excludes no difference, so the mean is statistically lower for Immediate Intervention than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
Change in Number of Hospitalizations During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
- 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:
- Immediate Intervention: mean -0.18 versus -0.08 on control; difference -0.10 (95% CI -0.37 to 0.17), standardized effect d = -0.19; z-test p = 0.472.
- Interpretation:
- The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Immediate Intervention and the control. The interval gives the range of effects that remain compatible with the data.
The posted secondary results cover quality of life on the EQ-5D-5L, depressive symptoms on the GDS Short Form, and change in hospitalization counts. Their patterns are not uniform: one comparison has an unadjusted difference whose recalculated confidence interval excludes zero, while the other two intervals include zero. This mix does not establish a consistent effect across all measured aspects of health and service use.
The secondary outcomes relate to the primary result by addressing different constructs. Functional status is the primary focus; quality of life and depressive symptoms are related but distinct self-reported measures, while hospitalization counts describe health-care use. Agreement or disagreement among these outcomes should therefore not be treated as a direct replication or contradiction of the PEP result. Each measure has its own scale, variability, and potential sources of missingness.
The registry lists additional secondary outcomes, including whether participants experienced hospitalization, emergency department visits, a move to a higher level of care, or a skilled nursing facility stay. Results for those listed outcomes are not reported in the registry record. The registry record lists 18 outcome measures and 8 secondary results posted, but does not report analyses for the secondary outcomes.
Secondary findings warrant less weight than a prespecified primary comparison when many outcomes are examined without a reported plan for controlling multiplicity. In general, testing multiple outcomes increases the chance that at least one result will appear notable by chance. The registry record does not report whether a multiplicity adjustment or hierarchy of outcomes was used. The secondary results are therefore best read as exploratory context for this pilot, rather than as a set of independent confirmations.
Secondary outcomes registered for this trial, for reference (only those above were recalculated):
- Change in EuroQol 5 Dimensions (EQ-5D-5L) Scale From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
- Change in Geriatric Depression Scale Short Form (GDS Short Form) Score From Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites
- Percentage of Participants With a Hospitalization During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
- Change in Number of Hospitalizations During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
- Percentage of Participants With an Emergency Department Visit During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
- Change in Number of Emergency Department Visits During the Study Period (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
- Percentage of Participants With a Move to a Higher Level of Care (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
- Percentage of Participants With a Skilled Nursing Facility Stay (Baseline to 2 Months for Immediate Intervention and Waitlist Control Sites)
9. Statistical Interpretation
The mean change in PEP functional status was -1.3 in the Immediate Intervention group and 0.6 in the Wait-list Control group. Since higher PEP scores indicate more impairment, the direction of the immediate group’s mean change is toward lower reported impairment, while the control group’s mean change is in the opposite direction. The unadjusted mean difference, calculated as immediate intervention minus wait-list control, was -1.9.
The recalculated 95% confidence interval for the mean difference excludes zero, and the unadjusted p-value is 0.016. Taken together, these results indicate that the observed mean changes differed between the groups in this analysis. The interval is also important: it describes a range of effect sizes compatible with the summary data under the calculation’s assumptions, rather than establishing a single exact effect. It does not resolve uncertainty about missing outcomes, measurement, or how well these pilot results would carry to another setting.
The comparison is based on 28 participants in the immediate group and 13 in the wait-list group for this outcome. The registry specifically notes loss to follow-up for self-reported measures and says the analyzed number does not match participant-flow figures. Accordingly, the result describes the analyzed outcome data; the record does not report enough detail to determine how missingness may have affected the comparison.
The calculated comparison is an unadjusted re-calculation from the posted group summaries. The registry record does not report a sponsor analysis for this endpoint, an adjusted estimate, or an analysis plan that would establish whether other covariates or procedures were used. The result should therefore be read as a pilot comparison of posted means, not as a complete account of every possible analysis of the trial.
The study was designed to examine feasibility and preliminary effectiveness, and the primary endpoint is one component of a broader set of outcomes. A group difference in mean change does not by itself establish that the intervention caused the difference, that the difference is meaningful to participants, or that it would persist beyond the measured period. The posted result is evidence about this particular comparison at 2 months, with the uncertainty and reporting limitations.
10. Statistical Methods Explained
The primary outcome is continuous: each participant has a score on a functional-status scale, and the registry reports the mean change and standard deviation for each group. A mean summarizes the group’s average change, while a standard deviation describes how much individual changes varied around that average. A group mean is not a description of every participant’s experience.
What does the mean difference represent?
The reported contrast is the Immediate Intervention mean change minus the Wait-list Control mean change. The group means are -1.3 and 0.6, respectively, giving a mean difference of -1.9. The negative direction means the immediate group had a lower average change score than the wait-list group. Because higher PEP scores represent greater functional impairment, the direction is consistent with a more favorable average change in the immediate group on this scale. That is a description of the score direction, not a conclusion about clinical importance.
The posted comparison is unadjusted. An unadjusted contrast compares the group summaries without accounting for other participant characteristics or additional model terms. Random allocation is intended to support a fair comparison, but it does not remove uncertainty arising from limited outcome data, missing responses, or differences that can occur by chance. The registry record does not report an adjusted analysis for the primary endpoint.
How should the confidence interval be understood?
A confidence interval describes the precision of an estimated contrast. In general, it gives a range of values compatible with the observed data under the calculation’s assumptions. A narrower interval indicates more precision than a wider interval, but neither interval width nor exclusion of zero establishes practical importance. For the primary comparison, the recalculated interval excludes zero, which is consistent with the direction of the unadjusted difference. The exact interval should be read alongside the scale definition and the missing-outcome note.
The interval is recalculated from the posted summary statistics, rather than presented as a sponsor-reported model result. The registry record does not report a sponsor analysis for the primary comparison. The reported arm-level means and standard deviations are the basis for the posted comparison; no adjusted estimate or alternative model is described in the registry record.
What does the p-value add?
The unadjusted p-value for the primary comparison is 0.016. In general, a p-value describes how unusual data at least as incompatible with a specified null model would be if that model were true and its assumptions held. It is not the probability that the null hypothesis is true, nor is it a measure of the size or importance of the difference. It also does not account for missing outcomes or multiple outcomes unless the analysis explicitly incorporates those issues. The registry record does not report a multiplicity adjustment for this endpoint.
Why can estimates for counts or other outcomes need different methods?
Statistical methods should match the outcome’s scale and distribution. For continuous scores, a comparison of means is a direct summary of average change. Counts such as hospitalizations may be concentrated at zero or vary more than a simple model expects. In general, over-dispersion means that observed variability exceeds what a basic count model assumes; ignoring it can make uncertainty estimates too small. The registry’s posted hospitalization outcome is presented as a mean change with a standard deviation, and the registry record does not report a model addressing count-specific features.
For binary outcomes, such as whether a participant had an event, analyses usually compare proportions or use a model for binary data. The registry lists several such outcomes, but the relevant results are not reported in the registry record. No additional statistical model should be inferred from the outcome names alone.
What is the status of the calculations?
The comparison statistics used for interpretation are unadjusted re-calculations from the posted group summaries. The registry record reports no analyses for the primary outcome and no reported analyses for the secondary outcomes. The registry record does not report details of a prespecified statistical analysis plan, assumptions used for the original trial design, interim analyses, or procedures for missing data. Those details cannot be inferred from the posted means, standard deviations, and comparisons.
The standard deviation describes variation among observed changes in a group; it is not the same as the standard error, which describes uncertainty in an estimated mean. Both can inform interpretation, but neither compensates for an outcome that is missing. Similarly, a standardized effect size can express a contrast relative to variability, but it does not give the contrast in the PEP scale’s original units. Interpretation should retain the scale’s direction and unit rather than relying only on a standardized summary.
11. Confidence Intervals and Precision
The primary mean difference is -1.9 PEP scale points, with a recalculated 95% confidence interval that excludes zero. This interval supports a difference in the direction of the observed mean contrast under the calculation’s assumptions. Its width reflects uncertainty in the estimated mean difference; it does not make the point estimate exact or indicate how participants’ individual outcomes were distributed.
Precision is limited by the number of observed primary outcomes: the analysis includes 28 participants in the Immediate Intervention group and 13 in the Wait-list Control group. The registry notes loss to follow-up for self-reported measures and a mismatch between the outcome analysis count and participant-flow figures. The handling and pattern of missing data are not reported in the registry record, so the interval does not describe uncertainty from every potential source of bias.
Confidence intervals are useful because they show both direction and a range of plausible effect sizes, whereas a p-value alone does not. Excluding zero is not the same as demonstrating that an effect is important to participants. The registry record does not report a threshold for a meaningful change on the PEP scale, so the clinical importance of the estimated difference is not established by the interval.
The reported interval is a recalculation from summary statistics, not a sponsor-reported adjusted interval. It assumes the comparison method used for the re-calculation is appropriate for these summaries. Details of the trial’s original analysis plan are not reported in the registry record. Thus, precision should be judged as the precision of this unadjusted summary comparison, rather than as a complete measure of certainty about the intervention’s effects.
12. Planning a Similar Trial: Sample Size
This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.
| Effect to detect | Participants per arm, 80% power | Participants per arm, 90% power |
|---|---|---|
| 100% of the observed effect | 18 | 24 |
| 75% of the observed effect | 32 | 43 |
| 50% of the observed effect | 71 | 96 |
The planning figures are participants per arm for 80% power and participants per arm for 90% power. They are not total event counts: the posted outcomes used for these illustrations are continuous measures. For the primary comparison, the illustrations give 18 participants per arm for 80% power and 24 for 90% power when planning for 100% of the observed effect. Planning for 75% of the observed effect gives 32 per arm for 80% power and 43 for 90%; planning for 50% gives 71 and 96, respectively.
These calculations use the stated assumptions: a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect equal to the stated fraction of the observed effect. The sample-size assumptions for the trial’s original design are not reported in the registry record. These illustrations are based on observed effects and are not observed power.
In plain language, the 80% power column describes the planning number per arm associated with an 80% chance of detecting the specified effect under the calculation’s assumptions, if that effect and the assumptions were correct. The 90% column uses a higher target chance of detection and therefore generally calls for more participants per arm. Smaller effects are harder to distinguish from random variation, so planning to detect a smaller fraction of the observed effect requires more participants. These figures are planning aids, not evidence that the original trial had those group sizes or used those assumptions.
13. How the Sample Size Is Derived
Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z1−α/2 = 1.960) and the desired power (z1−β = 0.842 for 80% and 1.282 for 90%).
Formula
n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.
Worked calculation for this trial
- Observed difference Δ = -1.900; pooled standard deviation σ = 2.020.
- n = 2 × (1.96 + 0.842)2 × 2.0202 / -1.9002 = 17.7, rounded up to 18 participants per arm for 80% power.
The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).
R code
alpha <- 0.05
z_a <- qnorm(1 - alpha / 2) # two-sided
delta <- -1.9 # observed difference in means
sigma <- 2.02009139168732 # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))
# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")
# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4212442)
n <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n)) # difference in sample means
s2 <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1)) # pooled sample variance
tstat <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))
Output from running the code
100% of observed effect: n per arm = 18 (80% power), 24 (90% power)
75% of observed effect: n per arm = 32 (80% power), 43 (90% power)
50% of observed effect: n per arm = 71 (80% power), 96 (90% power)
power.t.test: 18.8
Simulated power at n = 18 per arm: 0.781 (20000 replicates)
The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.
14. Multiplicity, Missing Data and Analysis Populations
The registry record lists 18 outcome measures, including the primary PEP functional-status outcome and 8 secondary results posted. The secondary outcomes span self-reported measures and health-care use. No reported analyses are listed for the primary comparison or the posted secondary comparisons. The re-calculated contrasts are unadjusted and should not be mistaken for a complete sponsor-reported analysis plan.
When many outcomes are examined, some apparently notable findings can arise by chance even if there is no true difference for the underlying outcomes. Statistical methods can address this multiplicity, for example by prespecifying a primary outcome or adjusting the interpretation of multiple tests. Whether the trial used such procedures, and what hierarchy or adjustment would have applied, are not reported in the registry record. The unadjusted secondary p-values therefore should not be read as if they were the only tests conducted.
Missingness is a specific concern for the primary endpoint. The registry record states that loss to follow-up for self-reported outcome measures means the number analyzed is not consistent with participant-flow figures. It does not report how many missing PEP responses occurred in each group, why responses were missing, whether missingness differed by participant characteristics, or how missing values were handled. Imputation, complete-case rules, sensitivity analyses, and assumptions about the missing-data process are not reported in the registry record.
The outcome analysis counts also vary across measures. The registry lists 28 and 13 analyzed for the primary PEP outcome, while other posted outcomes have different arm-level counts. Those differences mean that the results do not necessarily describe the same analysis population for every measure. The registry record does not report a detailed definition of the analysis populations or whether all randomized participants were included in any particular analysis.
The study description says outcomes would be examined by cognitive status, but subgroup results are not reported in the registry record. Interim analyses and the statistical plan are also not reported in the registry record. Without these details, readers cannot determine how the reported outcome set was selected or whether the displayed comparisons reflect every planned analysis.
15. 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 |
|---|---|---|---|
| Immediate Intervention | 0 | 47 | 0.0% |
| Wait-list Control | 0 | 28 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Immediate Intervention | 0 of 47 |
| Wait-list Control | 0 of 28 |
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 |
|---|---|
| Immediate Intervention | 0 of 47 |
| Wait-list Control | 0 of 28 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Immediate Intervention | Wait-list Control |
|---|---|---|---|
| Fall related to participating in intervention | Injury, poisoning and procedural complications | 0 of 47 | 0 of 28 |
The registry record lists 47 participants at risk for adverse events in the Immediate Intervention group and 28 in the Wait-list Control group. It records 0 serious adverse events and 0 other adverse events in each group, and 0 deaths in each group. No serious adverse-event terms are listed.
These figures describe what is recorded for the stated groups and safety categories. They do not show that no event of any kind occurred outside the record’s reporting definitions, and they do not establish the absence of risk. The at-risk counts also differ from some outcome analysis counts, so they should not be treated as the denominators for the primary endpoint.
The registry record does not report further detail about adverse-event definitions, collection procedures, severity grading, or the period during which safety events were actively monitored beyond the study-period descriptions. The figures should therefore be read as the registry’s reported safety counts, not as a comprehensive assessment of safety.
16. What the Result Does, and Does Not, Mean
The posted primary results show a lower average change in PEP functional impairment in the Immediate Intervention group than in the Wait-list Control group over the baseline-to-2-month period. The unadjusted mean difference is -1.9, and the recalculated confidence interval excludes zero. This is a result for the analyzed self-reported scores, not a direct measure of every aspect of aging in place.
The result does not establish that the intervention will produce the same effect in other populations or housing settings. The study is described as a pilot of feasibility and preliminary effectiveness, and the registry reports a completed randomized parallel-group design without masking. The primary analyzed counts are 28 and 13, and the registry notes loss to follow-up for self-reported outcomes. Missing-data methods and results by cognitive status are not reported in the registry record.
The result also does not establish how long any observed difference might persist. The primary comparison concerns baseline to 2 months; longer-term functional outcomes are not reported in the registry record. The registry does not report a threshold for a meaningful PEP change, so statistical separation from zero should not be equated with a known degree of importance to participants.
Nor does the primary result by itself settle questions about quality of life, depressive symptoms, hospitalizations, emergency care, or moves to higher levels of care. Those outcomes measure different aspects of experience and service use, and several listed outcomes do not have results reported in the registry record. The findings are best understood as a short-term, preliminary comparison on one functional scale, with uncertainty related to the size and composition of the analyzed outcome groups and to reporting gaps.
17. Why This Trial Matters Statistically
This trial raises statistical issues common to pilot studies that measure function and other outcomes in community settings. The primary endpoint is a self-reported scale with an interpretable direction: higher values indicate more impairment. That makes the sign of the mean change meaningful, while still requiring care not to confuse a group average with each participant’s experience.
The randomized parallel design gives a basis for comparing changes between an immediate intervention group and a wait-list group. But randomization does not remove the need to examine who contributed outcome data. The registry explicitly notes loss to follow-up for self-reported measures, and the analyzed groups for the primary endpoint are not the same as the listed enrollment. A transparent account of missing responses and the analysis population is important for interpreting any estimated contrast.
The trial also illustrates the distinction between a statistically detectable difference and a well-established, practically meaningful effect. The primary recalculated interval excludes zero, but a confidence interval and p-value do not determine the importance of a change on the scale. That judgment requires relevant interpretation of the measure, which is not specified in the registry record.
Finally, a set of related secondary outcomes can help describe whether a pattern extends across function, quality of life, mood, and health-care use. Yet multiple unadjusted comparisons can be difficult to interpret, particularly when the analysis plan and multiplicity procedures are not reported. The record’s combination of preliminary aims, unequal outcome counts, missingness, and unreported analysis details makes it especially useful to distinguish what the posted data show from what remains uncertain.
18. 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 28 participants in the Immediate Intervention group and 13 in the Wait-list Control group, while listed enrollment is 75. The registry record notes that loss to follow-up for self-reported measures makes the analyzed number inconsistent with participant-flow figures. It does not explain the extent, group distribution, reasons, or handling of missing primary outcome data. This limits assessment of possible bias as well as precision.
The primary endpoint is self-reported functional status. Such a measure is relevant to the study question, but its results reflect participants’ reports rather than an independently assessed performance measure. The study was unmasked, so participants and study staff were not masked according to the registry record. Whether expectations influenced reporting or assessment cannot be determined from the registry information.
The main comparison covers baseline to 2 months. The registry record does not report longer-term primary outcome results, so persistence of the observed change cannot be assessed. Although the study description states that outcomes would be examined by cognitive status, subgroup results are not reported in the registry record. The record also does not report the protocol’s statistical plan, missing-data procedures, or whether multiplicity was addressed.
The wait-list design compares immediate access with delayed access during the primary timeframe. The registry record does not describe an active comparison intervention during that period. Results from this comparison therefore do not isolate the intervention’s components from all possible differences in contact or expectations. These are interpretive limits of the available record, not evidence that any particular source of bias occurred.
19. Related Tutorials
20. Related Statistical Calculators
21. Sources
- ClinicalTrials.gov: Improving Aging in Place in Subsidized Housing — NCT04212442.
- Registry record last updated 2024-11-15; status last verified 2024-11.
- Results first posted 2024-11-15.
- 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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22. Record Summary
The registry record describes a completed randomized, unmasked, parallel pilot study of the Independent Living Program for Affordable Housing, an adapted telephone-based Function Focused Care intervention for older adults in subsidized housing. The Immediate Intervention group received the program upon enrollment; the Wait-list Control group began it two months after enrollment.
The primary outcome was change from baseline to 2 months on the self-reported PEP Functional Status Scale. The posted means were -1.3 for the immediate group and 0.6 for the wait-list group, with an unadjusted mean difference of -1.9. The recalculated confidence interval excludes zero, but the record notes loss to follow-up for self-reported outcomes and does not report the missing-data methods.
Secondary results show a mixed pattern, and results for several listed secondary outcomes are not reported in the registry record. The registry does not report sponsor analyses, the original statistical plan, or multiplicity procedures. The findings therefore describe a short-term pilot comparison and should be interpreted with attention to the analyzed outcome groups, uncertainty, and reporting limitations.