Advance Planning for Home Services for Seniors: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Advance Planning for Home Services for Seniors (NCT02256072), a randomized na study. The primary outcome is Planning Behavior Score at 1-month.

2. Clinical Question

The study addressed whether an online planning tool could support seniors in anticipating health needs and considering how to remain in their homes when those needs arise. Its registry description identifies falls, Alzheimer’s, dementia, and hospitalizations among the subject areas associated with the tool, although the description of its content is incomplete in the registry record.

The comparator was not an inactive group: participants assigned to Go4Life navigated an educational website about exercise and physical activity. The study description says this attention control was intended to account for the possibility that regular contact with the study team could itself influence outcomes. The two groups therefore received different online content, and the primary question concerns the comparison between those assigned approaches.

The primary endpoint was a planning behavior score at one month. The registry describes the score as ranging from 5-25 points, with higher values considered better. It planned to compare group means while controlling for baseline planning behavior. Numerical group results, an estimated between-group difference, and its uncertainty are not reported in the registry record, so the comparative finding cannot be determined from that record.

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. Participants were assigned to Plan Your Lifespan or Go4Life. The study is listed as completed, with a start date of 2014-09 and a primary completion date of 2015-12. The registry lists enrollment as 385. The phase is recorded as NA.

The intervention was a web-based planning tool designed to help seniors consider future health needs and plan for home services. The attention-control group used the Go4Life website, described as an electronic educational session about physical activity and exercise from the National Institute on Aging at NIH. The study description specifies a minimum of 15 minutes and a maximum of 45 minutes for navigating that site. The available descriptions of the intervention arms are incomplete, so further details of the tool’s content or how participants used it are not reported in the registry record.

The primary outcome was assessed at baseline and one month. The planned analysis population comprised all randomized participants with complete planning behavior scores at both of those assessments. Thus, although the registry lists randomized assignment, the stated primary analysis population is restricted by availability of the two score measurements.

The registry also lists secondary outcomes: planning perception at baseline, immediate post-test, 1 and 3-months; confidence in accessing home services and knowledge of home services at immediate post-test, 1 and 3-months; and satisfaction with the intervention tool at immediate post-test, 1 and 3-months. The registry lists five outcome measures and four analyses, but it does not give numerical findings for the primary endpoint in the information available. Details such as the randomization procedure, allocation concealment, recruitment setting, participant eligibility criteria, or specific enrollment targets 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: Enrolled participants were excluded from the trial before assignment to groups if they did not reach randomization (e.g. they did not reach ). All participants reached randomization.

Overall Study

Analysis population for the primary outcome, as defined in the registry: All randomized participants with a complete planning behavior score at baseline and one-month.

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 Planning Behavior Score at 1-month, measured over baseline and 1 month.

The primary endpoint was the Planning Behavior Score at 1-month. It is a continuous score from the Planning Implementation (Behavior) assessment, described as ranging from 5-25 points, with higher values considered a better outcome. The registry says the score was assessed at baseline and one month from baseline.

A behavior score is intended to reflect reported planning actions rather than only knowledge or confidence. That distinction is relevant to this study’s purpose: the intervention aimed to help seniors anticipate future needs and plan ways to remain at home. The registry also lists outcomes concerning planning perceptions, confidence in accessing home services, knowledge of home services, and satisfaction with the tool. These measure related but distinct aspects of participants’ responses; none should be treated as interchangeable with the primary behavior score.

Baseline score was included in the planned primary analysis as a covariate. In general, accounting for a baseline measure can make a follow-up comparison more informative by adjusting for initial differences in the outcome. The planned comparison was between mean one-month scores in the assigned groups, conditional on baseline score. The primary endpoint’s definition and planned analysis are described, but group means, the adjusted comparison, and an uncertainty interval are not reported in the registry record. The observed primary outcome result therefore cannot be characterized from the registry information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary analysis was specified as an analysis of covariance, or ANCOVA. In general, ANCOVA models a continuous follow-up outcome as a function of treatment group and one or more covariates. In this trial, the stated covariate was baseline planning behavior score, and the outcome was the one-month planning behavior score. The method estimates a group comparison adjusted for baseline score rather than relying only on a comparison of unadjusted follow-up means.

Why account for baseline score?

Participants can differ in planning behavior before receiving their assigned website. In general, including the baseline score can account for some of that initial variation and can improve the precision of a follow-up comparison when the baseline measure is informative about the follow-up measure. It also gives the analysis a defined way to address any chance baseline imbalance that may occur despite random assignment. Adjustment does not establish that the groups were identical at baseline, and it does not correct every possible source of bias. The registry does not report baseline score summaries or the fitted ANCOVA results.

What does the group comparison represent?

The planned analysis compares mean scores at one month between the randomized groups while controlling for baseline planning behavior. The score is continuous and ranges from 5-25 points, with higher values described as better. The comparison is about the outcome as measured by the Planning Implementation (Behavior) assessment; it is not automatically a measure of actual receipt of home services, remaining at home, or later health events. The registry does not report whether the measure was validated for these interpretations or provide details of its scoring beyond the stated range and direction.

How should statistical uncertainty be read?

In general, an estimate expresses the size and direction of a comparison, while a confidence interval communicates its uncertainty under the model and data assumptions. A narrow interval indicates greater precision than a wide interval, but precision is not the same as importance. A p-value addresses how compatible the observed data are with a specified null model under the analysis assumptions; it does not measure the probability that the null hypothesis is true, nor does it describe the size of an effect. The registry states a type I error rate of 5%, but does not report a primary endpoint p-value, confidence interval, or estimate.

What does randomization contribute?

In general, random assignment is intended to make treatment groups comparable with respect to measured and unmeasured characteristics at the time of assignment, on average. It supports interpretation of a between-group comparison, subject to the trial’s conduct, outcome measurement, missing data, and analysis choices. Randomization does not prevent follow-up data from being missing, ensure that participants follow their assigned approach, or establish that the observed analysis population remains comparable if outcome availability differs. The registry identifies the trial as randomized but does not describe the sequence-generation method, concealment process, adherence, or crossover.

What analysis details are absent?

The registry gives the intended ANCOVA, baseline adjustment, analysis population, and type I error rate. It does not report model diagnostics, handling of outliers, transformations, the covariate’s functional form, or procedures for missing outcomes. It also does not say whether analyses were adjusted for any additional factors or whether the analysis differed from the plan. Those details are not reported in the registry record and should not be inferred.

Statistical analysis plans concern how the data are summarized and compared; they do not substitute for result estimates. Here, the method can be explained from the registry description, while the empirical comparison and its precision remain unavailable in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple secondary outcomes assessed at different follow-up times, alongside the primary planning behavior endpoint at one month. When many outcomes or time-point comparisons are tested, the chance of obtaining at least one apparently unusual result can increase. In general, multiplicity procedures can address that issue by defining a testing hierarchy or adjusting inference across comparisons. The registry record does not report a multiplicity strategy, a hierarchy among secondary outcomes, or whether those analyses were considered exploratory.

The primary endpoint description specifies a type I error rate of 5%, but that alone does not establish how error rates were handled across the full set of outcomes or analyses. It also does not indicate whether interim analyses were conducted; that information is not reported in the registry record.

The planned primary analysis population included randomized participants with a complete planning behavior score at baseline and one-month. This is a complete-case population for the stated endpoint. The registry does not report missing outcome counts by group, reasons for missingness, or whether any methods beyond complete-case analysis were used. It does not describe imputation, sensitivity analyses, or assumptions about why measurements might be absent.

In general, complete-case results can be difficult to interpret if the availability of outcome data is associated with participants’ characteristics or outcomes. Randomized assignment does not by itself remove that concern once the analysis is restricted to people with observed scores. Without information on missingness and its handling, the extent to which it affects the planned comparison cannot be assessed. The record also does not report whether the primary analysis population differed from the set of all randomized participants in any other way.

11. Safety Results

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

Other (non-serious) adverse events

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

The registry’s adverse-event entries list zero serious adverse events and zero other adverse events for Plan Your Lifespan Website and for Go4Life Website. The groups’ serious-event and other-event at-risk counts are listed as 194 and 191, respectively. Death counts are null, so deaths are not reported in the registry record.

These entries describe what was recorded in the registry, not a complete account of every possible safety outcome. The registry does not provide event definitions, the observation period for adverse events, methods of collection, or further information about how events were assessed. It also does not report whether events were judged related to either website. A zero count in the listed categories should therefore be read as no events recorded in those fields, not as proof that no adverse experiences occurred.

The listed figures concern adverse-event reporting, not the primary planning behavior outcome. They do not establish whether either approach changed planning behavior, and they do not support a broad comparison of safety beyond the registry’s reported categories and information.

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

The record establishes that a randomized, parallel-group comparison was planned between a web-based advance-planning tool and an educational attention control. It also describes the primary endpoint, its direction, the one-month assessment, the intended baseline-adjusted analysis, and the analysis population. These details clarify what the trial set out to compare.

The record does not report numerical primary outcome results. Without group estimates and an adjusted comparison, it is not possible to say from the registry whether planning behavior scores were higher in either group, how large any difference was, or how precisely it was estimated. The absence of a reported result is not evidence of no difference; it means the outcome comparison cannot be evaluated using the registry information available.

Even if a statistical difference were reported, its interpretation would depend on the size and uncertainty of that difference, the meaning of the score, outcome completeness, and the quality of the analysis. Statistical significance by itself would not establish that an observed difference was important to participants or translated into changes in service planning or ability to remain at home. Those further outcomes are not reported as primary results in the registry record.

The trial compared two online approaches, with the attention-control website intended to account for contact with the study team. The comparison therefore would address the relative outcomes of the assigned approaches under the study conditions; it would not automatically answer how the planning tool compares with no website or no contact. The registry information does not describe adherence or actual use in enough detail to characterize exposure.

Accordingly, the strongest conclusion supported by the record is about the study’s design and measurement plan. It does not support a conclusion that the planning tool did or did not improve planning behavior, nor does it establish effects on health, service use, or living arrangements.

13. Why This Trial Matters Statistically

This trial is statistically notable for distinguishing a behavioral planning outcome from related outcomes such as knowledge, confidence, perception, and satisfaction. These measures address different aspects of a planning intervention. Keeping them distinct is important: a change in knowledge would not by itself demonstrate a change in planning behavior, and a behavior score would not by itself establish a change in service use or health.

The planned baseline-adjusted comparison is also relevant. For a continuous follow-up score, ANCOVA can account for baseline outcome values and estimate an adjusted difference between randomized groups. The method and the analysis population are described in the registry, which lets readers understand the intended question. However, the statistical plan is only one part of evaluating a trial: the estimate, its uncertainty, and information about missing outcomes are also needed to assess the findings.

The active attention control helps define the comparison. Participants assigned to the control navigated an educational website about exercise and physical activity, rather than receiving no study activity. The study description says this control was intended to address possible effects of regular contact with the study team. Thus, the design is framed around comparing two online experiences, not simply comparing an intervention with an absence of engagement.

Finally, the registry’s lack of numerical primary results illustrates an important boundary in trial interpretation. A completed study record and a defined analysis do not reveal the outcome unless results are reported. The available information supports discussion of how the trial was designed, but not a judgment about the size, direction, or precision of the primary comparison.

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 principal limitation for interpreting this trial from the registry record is the absence of numerical results for the primary endpoint. Group summaries, the adjusted comparison, and uncertainty measures are not reported. The record therefore cannot establish the direction or magnitude of the primary outcome finding.

The primary analysis population was defined by having complete baseline and one-month scores. The registry does not state how many participants met that condition, how many scores were missing, why they were missing, or how missingness was handled. Without those details, it is not possible to judge how complete-case selection may have affected the analysis.

The registry description gives limited details about the intervention and trial procedures. It does not report the randomization method, allocation concealment, recruitment setting, eligibility criteria, adherence, or use of the websites. The description of the Plan Your Lifespan content is incomplete, and the record does not explain how the planning behavior score was administered beyond its stated assessment name, range, and direction.

Multiple secondary outcomes are listed across several assessment times, but numerical results and multiplicity handling are not reported in the registry record. Details about interim analyses, protocol deviations, model assumptions, diagnostics, and sensitivity analyses are also not reported. These omissions limit assessment of the analysis beyond the planned ANCOVA description.

The adverse-event entries contain zero recorded events in the listed categories, but the registry does not describe event collection or follow-up in enough detail to assess the completeness of safety reporting. These limitations concern interpretation of the registry information; they do not establish that the trial itself lacked procedures that are simply not described in the record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Advance Planning for Home Services for Seniors — NCT02256072.
• Registry record last updated 2017-04-14; status last verified 2017-03.
• Results first posted 2017-02-14.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry describes a completed randomized, parallel-group trial without masking, comparing Plan Your Lifespan with the Go4Life educational attention control. It lists enrollment as 385 and a primary completion date of 2015-12.

The primary endpoint was the Planning Behavior Score at 1-month, a continuous measure ranging from 5-25 points, with higher values considered better. The planned analysis was ANCOVA comparing mean one-month scores while controlling for baseline score, among randomized participants with complete scores at baseline and one-month. The stated type I error rate was 5%.

The registry lists secondary outcomes at multiple assessment times, but numerical primary endpoint results and details of missing-data handling are not reported in the registry record. The adverse-event entries record zero serious and zero other adverse events in both groups; deaths are not reported.