Community Spirit in Residence for the Elderly: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Community Spirit in Residence for the Elderly (NCT06441877), a registered phase not stated study. The primary outcome is Sense of Community.

2. Clinical Question

This is a descriptive question about experiences and perceptions in a residential context, not an estimate of the effect of an assigned treatment. Residents and managers represent distinct perspectives: residents answer about their own sense of community, while managers’ measure concerns their perception of residents’ sense of community. The record also identifies two secondary outcome topics, facilitators and obstacles to a sense of community. Its stated objectives are to explore and understand factors that support or challenge social participation and community spirit.

The registry lists no intervention and does not describe a randomized allocation. It therefore does not establish a causal comparison between sites, roles, or any treatment conditions. Differences in scores, if reported elsewhere, would need to be interpreted as descriptive contrasts within this study context rather than as effects attributable to a specific intervention. The numerical outcome results are not reported in the registry record, so the primary question cannot be answered from the posted results.

3. Trial Design

The record describes a completed study titled “Community Spirit in Residence for the Elderly.” Its official title is “The Elder at the Heart of His or Her Living Environment - Social Participation and Community Spirit in Residence for the Elderly.” TOPMED is listed as the sponsor, and the condition is Sense of Community. The study dates recorded are 2024-05-07 for the start and 2024-06-04 for primary completion. Enrollment is 27.

The listed intervention is “No intervention,” categorized as OTHER. Four groups are described: elderly residents at site 1, elderly residents at site 2, managers working for the elderly home care service at site 1, and managers working for the service at site 2. These are groups defined by participant role and site. The registry record explicitly notes that this is not a randomized comparison, that allocation is not stated, and that the arms are not a like-for-like control comparison. The record does not describe an assigned treatment contrast.

The primary outcome is Sense of Community, measured as a score on a scale. The stated timeframe is up to two weeks prior to the interview session. Residents complete a nine-item questionnaire about their sense of community; for managers, the measure is their perception of residents’ sense of community. Each item uses a five-point scale, and higher scores indicate higher sense of community. The record also names Sense of Community Facilitators and Sense of Community Obstacles as secondary outcomes.

Although the study status is COMPLETED, the record lists zero analyses and gives no numerical outcome results. The interview procedures, recruitment details, allocation process, and analysis methods are not reported in the registry record. The stated objectives are exploratory: to understand facilitators and challenges of social participation and of creating a sense of community in residential settings. Those objectives and the listed measures describe what the study set out to examine, but they do not substitute for posted findings.

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

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Sense of Community, measured over Up to two weeks prior to the interview session.

The primary endpoint is Sense of Community, recorded as a score on a scale. The registry describes a nine-item questionnaire. Each item uses a five-point response scale, with a minimum item value of 1 and a maximum item value of 5. The stated minimum total score is 9 and the stated maximum total score is 45. Higher scores mean higher sense of community.

For residents, the measure is intended to represent their own sense of community. For managers, it represents their perception of residents’ sense of community. These are related but distinct viewpoints, so results for the two roles should not automatically be treated as interchangeable measurements of the same respondent experience. The registry does not report whether the questionnaire was administered or scored in any additional way.

The measure is relevant to the study’s objectives because the study seeks to understand community spirit and participation in residential settings. A numerical score can describe responses on the questionnaire’s defined scale. A mean can summarize the average score within a group, while a standard deviation describes how spread out scores are around that mean. Such summaries alone do not explain why participants gave their responses, and the registry’s exploratory objectives also concern facilitators and challenges.

The stated timeframe is up to two weeks prior to the interview session. The record does not give the actual score values, group means, standard deviations, confidence intervals, or tests for this endpoint. Consequently, the posted results do not indicate the level of sense of community reported by residents or perceived by managers.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record identifies the primary measure as a continuous score and specifies mean and standard deviation as the intended summary quantities. It does not report an analysis plan or results. The explanations below are general statistical context; they should not be read as a description of analyses actually performed in this study.

What does a mean summarize?

For a continuous outcome, the mean is the arithmetic average of the observed scores in a defined group. It gives a compact description of the group’s score level, but it does not show whether scores are clustered near the mean or widely dispersed. The standard deviation describes the typical spread of individual observations around the mean. Together, a mean and standard deviation can help readers distinguish a group with tightly clustered scores from one with more variation.

For this endpoint, the questionnaire’s score range is from 9 to 45, with higher scores representing a higher sense of community. The scale’s bounded range matters when interpreting summaries: a mean is a summary of responses on this particular scale, not a direct measure of every aspect of community life. A mean also does not reveal the distribution of scores, the proportion at any score level, or individual experiences. The record does not post group means or standard deviations.

What would a comparison mean?

A statistical comparison requires a clearly defined estimand: the population, outcome, groups, and contrast of interest. A difference between site-specific means would address a different question from a contrast between residents’ scores and managers’ perceptions. The role groups do not provide the same respondent perspective, and the record cautions that the groups are not a like-for-like control comparison. A simple numerical contrast, if available, would therefore require a careful statement of what it compares.

General statistical context: an unadjusted comparison summarizes the observed difference without accounting for other variables. An adjusted analysis may account for specified characteristics, but the variables and model must be prespecified or otherwise transparently described. Adjustment does not automatically remove bias, and the choice of model depends on the study question, design, and data. The registry record does not report a statistical model, covariate adjustment, or an analysis plan, so it is not possible to attribute any particular method to this study.

How should uncertainty be read?

A confidence interval gives a range of estimates compatible with the data and the interval procedure’s assumptions. A narrower interval generally indicates greater precision than a wider interval, but precision is not the same as freedom from bias. A confidence interval for a group mean would describe uncertainty in that mean; an interval for a difference would describe uncertainty in the contrast. These are different quantities and answer different questions. No confidence intervals are reported for the primary outcome.

A p-value is calculated relative to a specified null hypothesis and statistical model. It is not a measure of the size or practical importance of an association, and it does not establish causation. A small p-value alone cannot address confounding, selection, measurement limitations, or generalizability. The registry record contains no reported p-values or tests for the primary or secondary outcomes.

Why does the group structure matter?

The study includes residents and managers at two sites. Observations from people within the same site may share aspects of their environment, and general statistical methods may need to account for clustering when the design and data warrant it. Ignoring relevant clustering can make standard errors too small and confidence intervals too narrow. This is a general consideration, not a claim that clustering was present in a particular quantified form or that a clustered analysis was used. The registry record does not report whether site clustering was considered.

The manager outcome is explicitly described as a perception of residents’ sense of community. It should not be interpreted as a direct resident questionnaire response. Keeping the role-specific meaning clear is important when presenting group summaries or considering comparisons. The record does not report how many managers or residents completed the questionnaire in each site group, nor whether any responses were missing.

What does the sample-size illustration show?

The record describes a planning illustration based on the observed effect. It specifies a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. For non-time-to-event calculations, the stated quantity is participants per arm. The numerical sample-size outputs, observed effect, and the details needed to evaluate the illustration are not reported in the registry record.

General statistical context: planning calculations depend on assumptions about the effect to detect, variability, significance level, power, allocation, and analysis method. Changing an assumption can change the required sample size. A calculation based on an observed effect is particularly dependent on the estimate used. A planning illustration is not observed power, does not demonstrate that the completed study was adequately powered, and cannot replace an estimate with an uncertainty interval. Because outcome results and analysis details are absent, the illustration cannot be independently interpreted from the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Residents Site 1", "Residents Site 2", "Managers Site 1", "Managers Site 2")
n   <- c(8, 10, 5, 3)
m   <- c(36.9, 36.8, 38.6, 36.3)
sp  <- c(3, 3.2, 1.9, 3.2)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Residents Site 1  8  36.900  3.000  34.392  39.408
CARM  Residents Site 2  10  36.800  3.200  34.511  39.089
CARM  Managers Site 1  5  38.600  1.900  36.241  40.959
CARM  Managers Site 2  3  36.300  3.200  28.351  44.249

11. Multiplicity, Missing Data and Analysis Populations

The registry names Sense of Community as the primary outcome and lists Sense of Community Facilitators and Sense of Community Obstacles as secondary outcomes. It also states that there are four outcome measures, but it does not describe all four measures in the posted information. The record lists zero analyses and does not report results for the primary or secondary outcomes.

Multiplicity arises when several outcomes, comparisons, or analyses are examined. General statistical context: the more statistical tests conducted, the greater the chance that at least one result may appear notable by chance if each test is interpreted separately. Researchers can address this through a prespecified hierarchy, adjustment procedures, or a clear distinction between confirmatory and exploratory analyses. The registry record does not report a multiplicity strategy, a testing hierarchy, or which results, if any, were treated as confirmatory. No claim about multiplicity adjustment can therefore be made.

Missing-data handling is also not reported in the registry record. There are no outcome-specific denominators, counts of incomplete questionnaires, reasons for missingness, or descriptions of any imputation or other handling method. General statistical context: missingness can affect both the size and representativeness of the analyzed sample, and its consequences depend on why data are absent and on the method used to address them. The total enrollment does not establish how many complete primary-outcome scores were available.

The record does not define analysis populations, such as a population based on all enrolled participants or a population with completed outcome measurements. Nor does it report exclusions, protocol deviations, or the handling of participants who may not have contributed a score. These omissions make it impossible to determine which participants underlie any outcome estimate; no numerical outcome estimates are posted in any case.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry lists serious adverse events, other adverse events, and deaths for each of the four groups. For Residents Site 1, 8 were at risk for serious events and 0 were affected; 8 were at risk for other events and 0 were affected; deaths were 0. For Residents Site 2, the corresponding figures were 11 at risk for serious events and 0 affected, 11 at risk for other events and 0 affected, and 0 deaths. For Managers Site 1, 5 were at risk for serious events and 0 affected, 5 were at risk for other events and 0 affected, and 0 deaths. For Managers Site 2, 3 were at risk for serious events and 0 affected, 3 were at risk for other events and 0 affected, and 0 deaths.

These are the registry’s recorded event counts and at-risk counts. They describe what was entered for the listed groups; they do not establish that no events occurred outside the record’s ascertainment or reporting. The registry does not list serious adverse event terms. The listed intervention is “No intervention,” so these group figures should not be interpreted as a comparison of harms between assigned treatments. The record does not report additional safety-monitoring details or event definitions.

General statistical context: zero recorded events in a group is not proof that the underlying event risk is zero. The precision of a safety estimate depends on the amount and duration of observation, the event definition, and the completeness of reporting. The registry record does not provide enough information to quantify those factors.

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

The record establishes that a completed study enrolled 27 people and sought to understand social participation and a sense of community in residential settings. It describes a nine-item questionnaire, the scale’s scoring range, the direction of higher scores, the roles and sites represented, and two secondary outcome topics. These details clarify the study’s subject and measurement approach.

What the record does not establish is the actual level of sense of community in any group. It does not report primary or secondary outcome values, group means, standard deviations, comparisons, uncertainty intervals, or analyses. The registry lists zero analyses. As a result, readers cannot determine from the posted results whether scores were high or low on the scale, how much scores varied, or whether residents and managers expressed similar or different views.

The design also does not support a treatment-effect interpretation. No intervention is listed, allocation is not stated, and the record cautions that the groups are not a like-for-like control comparison. The resident and manager groups answer different versions of the underlying question: managers report their perception of residents’ sense of community. Any contrast between roles or sites would be descriptive unless a suitable design and analysis established a more specific interpretation.

General statistical context: an observed association or difference does not, by itself, identify its cause. Contextual factors, group composition, measurement, and selection can influence observed results. Statistical precision, even when available, addresses uncertainty under an analysis model but does not resolve all design limitations. No such precision estimates are reported for the outcomes.

The zero event counts in the adverse-event listings are a record of reported counts in the specified groups, not proof that risk is absent. Overall, the registry supports understanding what the investigators aimed to measure and how the groups were organized. It does not support a conclusion about the study’s outcome findings or about the effectiveness of any intervention.

14. Why This Trial Matters Statistically

This study is statistically noteworthy because its question concerns a construct that is not directly observed in the same way for every participant. Residents report their own sense of community, while managers report their perception of residents’ sense of community. Keeping those perspectives distinct is important when defining the outcome, summarizing it, and deciding whether any comparison is meaningful.

The four group labels also combine site and participant role. A reader needs to know which group is being described and what a score represents before interpreting a summary. The registry explicitly warns that the groups do not form a like-for-like control comparison. That caution is central: descriptive differences across sites or roles would not automatically represent causal effects.

The record provides useful measurement details, including the nine-item questionnaire, its score limits, and the direction of interpretation. It also identifies exploratory objectives around facilitators and obstacles to social participation and community spirit. Yet the lack of posted numerical results means that the measure’s observed distribution and the uncertainty around any estimate cannot be assessed. Reporting a measure’s structure is not the same as reporting what participants scored.

General statistical context: transparent outcome reporting should connect the study question to the analysis population, outcome definition, summary statistics, comparisons, and uncertainty. For a multi-outcome study, readers also benefit from knowing which results were primary, how secondary results were treated, and how missing observations were handled. Those details are not reported in the registry record. The absence of these details limits reproducibility and prevents an independent assessment of the strength and precision of findings.

The record also illustrates why planning calculations and observed results must be kept separate. A sample-size illustration can show the implications of stated planning assumptions, but it is not a substitute for reported estimates and does not establish observed power. In this study, the numerical illustration outputs and outcome findings are not reported. The statistical significance of the record therefore lies in recognizing the distinction between a clearly described research question and results that are not available for evaluation.

15. 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 main trial-specific limitation of the registry record is that it contains no numerical results for the primary endpoint or the named secondary outcomes. Although the study status is COMPLETED, the record lists zero analyses. It therefore does not show outcome scores, group summaries, comparisons, or uncertainty estimates. The extent to which the objectives were addressed cannot be judged from the posted results.

Enrollment is 27, but the record does not state how participants were divided among the groups for outcome analysis or how many completed the questionnaire. It does not provide group-specific outcome denominators, participant characteristics beyond role and site, or information about incomplete responses. The analysis population and missing-data handling are not reported in the registry record.

The group structure requires caution. Residents and managers represent different respondent roles, and the manager measure is a perception of residents’ sense of community. The record also warns that the groups are not a like-for-like control comparison and that allocation is not stated. These features limit the interpretation of any potential between-group contrast, even if numerical values were available. The registry does not report a method for accounting for site or other contextual differences.

The measure’s stated range and scoring direction are reported, but the registry does not provide information about questionnaire validation, administration procedures beyond the timeframe, or how the secondary outcomes were operationalized. The stated outcome-measure count is four, while only the primary and two secondary outcome topics are named in the posted information. Analysis methods, multiplicity handling, and sample-size illustration outputs are also not reported in the registry record.

The adverse-event listings contain zero recorded events for the listed categories, but event definitions, ascertainment procedures, and other safety-monitoring details are not reported. These limitations concern interpretation of the registry record and should not be taken as evidence that the study was conducted improperly.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Community Spirit in Residence for the Elderly — NCT06441877.
• Registry record last updated 2025-04-20; status last verified 2025-04.
• Results first posted 2025-04-20.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT06441877 is a completed study sponsored by TOPMED, with enrollment of 27. The record describes an observational study with no intervention listed, involving residents and managers at two elderly home care service sites. Its objectives concern facilitators and challenges to social participation and a sense of community in residential settings.

The primary outcome is a nine-item Sense of Community questionnaire, scored from 9 to 45, with higher scores indicating higher sense of community. Residents report their own sense of community; managers report their perception of residents’ sense of community. The timeframe is up to two weeks prior to the interview session. Secondary outcome topics are Sense of Community Facilitators and Sense of Community Obstacles.

The record cautions that allocation is not stated and the groups are not a like-for-like control comparison. It lists zero analyses and does not report numerical outcome results, analysis methods, missing-data handling, or multiplicity procedures. Adverse-event listings report zero affected for serious and other events and zero deaths in each group, with the group-specific at-risk counts recorded separately. The posted information describes the study’s aims and measures but does not establish its outcome findings.