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 "Safety in Dementia": An Online Caregiver Intervention (NCT05173922), a randomized na study. The primary outcome is Preparation for Decision Making.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05173922 |
| Phase | NA |
| Condition | Caregivers, Decision Making, Alzheimer Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 500 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Colorado, Denver |
| Results posted | Yes |
2. Clinical Question
Population
Informal caregivers of community-dwelling adults with dementia who have firearm access were the intended participants. The study description specifies national recruitment and longitudinal follow-up. The primary outcome population is described as 492 participants with a Preparation for Decision Making score at at least one assessment time point.
Intervention
Safety in Dementia is an online tool that guides a caregiver through decisions related to firearm access for a person with dementia. The description says it presents information and compares options, including their risks and benefits. The available intervention description ends while describing further guidance, so additional details are not reported in the registry record.
Comparator
The web control group viewed the National Institute on Aging Home Safety Checklist. The registry record does not give further detail about how participants used the checklist or whether they received other study materials.
Primary question
The primary outcome is Preparation for Decision Making, a score intended to reflect how useful a decision aid is in preparing someone for subsequent decision-making. The comparison of interest is the score after assignment to Safety in Dementia versus the web control across the stated assessment times. The registry record does not report outcome results or a single primary comparison.
3. Trial Design
This was a randomized, triple-masked, parallel-group trial of a behavioral intervention. The registry record lists an enrollment of 500 and a completed status. It gives a start date of 2022-05-22 and a primary completion date of 2024-10-11. The listed phase is NA. The record describes national recruitment and longitudinal follow-up of informal caregivers of community-dwelling adults with dementia who have firearm access.
Participants were assigned to Safety in Dementia or a web control. The intervention is an online tool focused on decisions about firearm access for a person with dementia. The control group viewed the National Institute on Aging Home Safety Checklist. The registry record labels the study as parallel-group and triple-masked, but does not report who was masked or how masking was implemented. The method used to generate the randomization sequence and the process used to conceal allocation are not reported in the registry record.
The primary outcome was Preparation for Decision Making. Assessments were planned at baseline, after participants received their randomization allocation, and at 2 weeks, 2 months, and 6 months. The baseline timing means that the listed baseline assessment followed assignment; the record does not explain the rationale or describe whether a separate pre-assignment measure was collected.
The record lists secondary outcomes involving decision self-efficacy, firearm access, actions to reduce access, firearm injury, caregiver burden, and positive aspects of caregiving. It does not provide reported results for these outcomes. Although the trial is marked completed, completion status alone does not establish that results have been posted. The registry record contains no analysis entries.
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: Of N = 522 eligible participants who consented and were sent the survey invitation, N = 22 did not begin the survey or stopped completing the survey before randomization and viewing of the control or Safe at Home information. Therefore, the sample is comprise of N = 500 individuals who were enrolled and randomized.
Baseline
| Stage | Web Control | Safety in Dementia |
|---|---|---|
| STARTED | 249 | 251 |
| COMPLETED | 249 | 251 |
| NOT COMPLETED | 0 | 0 |
2-week Follow-up
| Stage | Web Control | Safety in Dementia |
|---|---|---|
| STARTED | 249 | 251 |
| COMPLETED | 234 | 242 |
| NOT COMPLETED | 15 | 9 |
Reasons for not completing this period:
| Reason | Web Control | Safety in Dementia |
|---|---|---|
| Missing visit | 15 | 9 |
2-month Follow-up
| Stage | Web Control | Safety in Dementia |
|---|---|---|
| STARTED | 249 | 251 |
| COMPLETED | 236 | 235 |
| NOT COMPLETED | 13 | 16 |
Reasons for not completing this period:
| Reason | Web Control | Safety in Dementia |
|---|---|---|
| Withdrawal by Subject | 1 | 1 |
| Missed visit | 12 | 15 |
6-month Follow-up
| Stage | Web Control | Safety in Dementia |
|---|---|---|
| STARTED | 248 | 250 |
| COMPLETED | 229 | 227 |
| NOT COMPLETED | 19 | 23 |
Reasons for not completing this period:
| Reason | Web Control | Safety in Dementia |
|---|---|---|
| Withdrawal by Subject | 3 | 6 |
| Missed visit | 16 | 17 |
Analysis population for the primary outcome, as defined in the registry: N = 492 of 500 total participants have a preparation for decision making total score at at least one time point (baseline, two week, two month, and/or six 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.
| Characteristic | Unit | Web Control | Safety in Dementia | Total |
|---|---|---|---|---|
| Participants analysed | 249 | 251 | 500 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 202 | 216 | 418 |
| Age, Categorical: >=65 years | Participants | 39 | 30 | 69 |
| Age, Continuous | years | 47.6 (SD 15.5) | 46.4 (SD 14.6) | 47.0 (SD 15.0) |
| Sex: Female, Male: Female | Participants | 171 | 162 | 333 |
| Sex: Female, Male: Male | Participants | 70 | 82 | 152 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 3 | 5 |
| Race (NIH/OMB): Asian | Participants | 5 | 7 | 12 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 74 | 70 | 144 |
| Race (NIH/OMB): White | Participants | 150 | 156 | 306 |
| Race (NIH/OMB): More than one race | Participants | 7 | 7 | 14 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 11 | 8 | 19 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 22 | 22 | 44 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 211 | 217 | 428 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 16 | 12 | 28 |
| Region of Enrollment: United States | participants | 249 | 251 | 500 |
| Preparation for decision-making | units on a scale | 64.8 (SD 26.9) | 69.8 (SD 22.0) | 67.3 (SD 24.7) |
6. Primary Endpoint
The registry lists the primary outcome as Preparation for Decision Making, measured over During baseline assessment (specifically, after receiving randomization allocation), 2 weeks, 2 months, 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
Preparation for Decision Making is intended to measure a participant’s perception of how useful a decision aid is in preparing for subsequent decision-making. The registry describes the scale as being based on 10 constructs, each rated from 1, not at all, to 5, a great deal. Item responses are averaged and converted to a 0-100 total score, with higher scores indicating a higher perceived level of preparation. The registry also describes the scale as having high test reliability (0.944) and as discriminating between different decision support interventions.
This is a continuous outcome: it describes a range of reported preparation scores rather than simply whether a participant did or did not reach a particular state. The outcome is relevant to an intervention designed to support a decision process, because it asks about perceived preparation rather than recording the decision itself. It does not, by itself, establish whether a caregiver made a particular choice, whether firearm access changed, or whether any safety outcome occurred.
The assessment schedule includes baseline after randomization allocation, 2 weeks, 2 months, and 6 months. The registry record does not report the primary outcome values, estimates comparing the groups, confidence intervals, or a statistical test. It also does not specify which assessment time or combination of times was intended to anchor the primary treatment comparison. Consequently, the endpoint’s definition is available, but its comparative result is not.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the trial design and intended primary outcome, but it does not report a primary outcome estimate or analysis. It is therefore not possible to describe whether Preparation for Decision Making scores differed between the Safety in Dementia group and the web control, how large any difference was, or how precisely it was estimated. No treatment-effect conclusion can be drawn from the posted record.
The record states that 492 of the 500 total participants had a Preparation for Decision Making total score at at least one of the assessment times. This is a count of participants with a score at one or more time points; it is not a report that every participant contributed a score at every assessment. The record does not give the number assessed at each time, the distribution of scores, or reasons for missing assessments. The enrollment figure and the count with at least one score do not, without additional information, explain the pattern of missing data.
The registry lists the primary outcome at baseline after randomization allocation and at 2 weeks, 2 months, and 6 months. Because no analysis is reported, the record does not establish whether the primary comparison was based on a particular follow-up time, change from baseline, or a model combining repeated measurements. Those alternatives can answer different questions, and their interpretation depends on the analysis specification. The record does not report that specification.
Some safety counts are posted. The web control group lists 9 serious adverse events among 249 participants at risk, and Safety in Dementia lists 11 among 251 at risk. Other adverse event counts are 36 among 249 in the web control group and 31 among 251 in Safety in Dementia. The record lists no deaths in either group. These counts are descriptive; the registry does not provide definitions, event-level details, statistical comparisons, or an explanation of how the counts relate to individual participants. The serious-event term listed is suicide ideation or attempt in a caregiver or individual with dementia, with 4.4% recorded. That term should not be mistaken for a primary outcome finding.
In short, the registry supports a description of the trial and its outcome plan, and provides selected adverse-event counts. It does not provide the comparative primary outcome results needed to assess the intervention’s measured effect or its precision. Completion status is not a substitute for posted outcome analyses.
9. Statistical Methods Explained
What does a continuous outcome mean?
Preparation for Decision Making is a continuous score. In general, a continuous measure can take a range of values, and an analysis may describe its mean and variability in each group. The registry identifies the intended summary as a mean with standard deviation. A mean describes the group’s average score; a standard deviation describes how dispersed individual scores are around that average. Neither summary is reported for this trial, so the registry record does not allow readers to assess the observed score distributions.
The scale is converted to a 0-100 range, and higher scores are described as indicating greater perceived preparation. This direction helps interpret a reported group contrast if one is available. It does not permit a conclusion without the actual group values, an effect estimate, and an indication of uncertainty. Those results are not reported in the registry record.
How would a group comparison be interpreted?
In general, a randomized comparison estimates how the outcome differs between groups under the assigned study conditions. A difference in means is one possible summary for a continuous endpoint. A confidence interval would describe the range of effects compatible with the data and the analysis assumptions; a narrower interval generally indicates greater precision than a wider interval. A p-value, if reported, would summarize how compatible the observed data are with a specified null hypothesis under the chosen model. Neither a confidence interval nor a p-value alone describes the practical importance of an effect.
For this trial, no mean by group, between-group estimate, confidence interval, or p-value is reported. The record therefore does not permit an assessment of direction, magnitude, precision, or statistical evidence for the primary outcome. No recalculated comparison is available in the registry record, and there is no sponsor analysis to compare against a recalculation.
Why does the assessment schedule matter?
The primary outcome is listed at baseline after randomization allocation and at 2 weeks, 2 months, and 6 months. Repeated assessments can be analyzed in different ways. An analysis might focus on one follow-up assessment, compare change from a baseline measure, or use a model to account for scores observed over time. These are general approaches, not claims about the method used in this trial. The registry record does not state which approach was planned or used, nor does it identify a single time point as the primary comparison.
When multiple measurements are collected, within-participant scores may be related rather than independent. A repeated-measures model can account for that relationship if appropriately specified. Such models also require decisions about the covariance structure, how missing observations are handled, and what effect is being estimated. These details are not reported in the registry record. Without them, readers cannot reconstruct the primary analysis from the outcome schedule alone.
What does masking tell readers?
The trial is labeled triple-masked. In general, masking is intended to limit the influence of knowledge about assigned group on study conduct, outcome assessment, or reporting. The registry record does not identify which parties were masked, how masking was maintained, or whether participants could infer their assignment from the online materials. The label alone does not establish the success of masking.
How should sample-size illustrations be read?
General sample-size illustrations can show how the number of participants needed for a future study varies with the effect one wishes to detect and the assumptions used. The assumptions described for this trial’s planning illustration include a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The illustration is described as based on a fraction of the observed effect. These are planning assumptions, not evidence about the original design or the precision achieved in this trial.
The registry record does not report the trial’s own sample-size justification, the target effect used in its design, or an account of how enrollment was determined. Any sample-size illustration should therefore be read as a planning exercise rather than as the original protocol’s justification. It is not observed power. Sample-size calculations cannot replace a reported effect estimate and confidence interval, and they do not establish whether the primary analysis was adequately specified or successfully completed.
Why can event counts need more context?
Adverse-event counts describe recorded events under the registry’s reporting conventions. To compare groups or interpret risk, readers generally need event definitions, ascertainment procedures, denominators suited to the event, and details about whether counts refer to events or people. For serious events, timing and relatedness may also matter. The registry record gives group counts and participants at risk but does not report these additional details or a statistical comparison. The posted counts should therefore be read as descriptive information, not as a complete comparative safety analysis.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is assessed at baseline after randomization allocation, 2 weeks, 2 months, and 6 months. Multiple assessment times can create multiple opportunities to compare groups. In general, testing several outcomes or time points can increase the chance of a chance finding unless the analysis plan addresses multiplicity. The registry record does not report a multiplicity strategy, a hierarchy of tests, or which assessment time was designated as the primary comparison. It also does not report a statistical analysis plan that would clarify how the outcome times were to be handled.
The record lists seven outcome measures and names secondary outcomes concerning decision self-efficacy, firearm access, actions to reduce access, firearm injury, caregiver burden, and positive aspects of caregiving. No results for these outcomes are reported. Without a stated testing strategy, readers cannot determine whether any future reported secondary findings would be confirmatory or exploratory, or how to interpret their statistical evidence across outcomes.
For the primary outcome, 492 of 500 participants are reported to have a total score at at least one time point. The registry does not report the number with scores at each assessment, reasons for missing data, or the methods used to address missing observations. It does not state whether analyses included all randomized participants, only participants with observed outcomes, or another analysis population. The registry record therefore does not establish the missing-data assumptions or analysis population used for any treatment-effect estimate.
There are no analysis entries in the registry record. This does not establish that no analyses were conducted; it means that the record does not provide an analysis to evaluate. The choice of time point, population, missing-data method, and multiplicity approach cannot be recovered from the posted outcome descriptions alone.
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 |
|---|---|---|---|
| Web Control | 9 | 249 | 3.6% |
| Safety in Dementia | 11 | 251 | 4.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Web Control | 0 of 249 |
| Safety in Dementia | 0 of 251 |
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 |
|---|---|
| Web Control | 36 of 249 |
| Safety in Dementia | 31 of 251 |
Most frequent serious adverse event terms
| Event term | Organ system | Web Control | Safety in Dementia |
|---|---|---|---|
| Suicide ideation or attempt in caregiver or individual with dementia | Social circumstances | 9 of 249 | 11 of 251 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Web Control | Safety in Dementia |
|---|---|---|---|
| Any negative verbal interaction between caregiver and person with dementia from intervention | Social circumstances | 36 of 249 | 30 of 251 |
| Any negative physical interaction between caregiver and person with dementia from intervention | Social circumstances | 1 of 249 | 1 of 251 |
Serious events with the highest arm-level rate: suicide ideation or attempt in caregiver or individual with dementia (4.4%).
The registry lists serious adverse-event counts for each group: 9 among 249 participants at risk in the web control group and 11 among 251 participants at risk in Safety in Dementia. It lists other adverse-event counts of 36 among 249 in the web control group and 31 among 251 in Safety in Dementia. The death count is 0 for each group. These are the posted counts and denominators; no additional comparison has been calculated.
The record identifies suicide ideation or attempt in a caregiver or individual with dementia as the leading serious adverse-event term and gives 4.4%. It does not state the denominator or calculation underlying that percentage, or provide a breakdown by group, event severity, timing, or relationship to study participation. The registry also does not explain whether the counts represent events or people, how events were collected, or how seriousness was defined.
These figures are descriptive registry entries, not a complete safety analysis. They do not show whether an event was caused by an intervention or establish a comparative risk. The absence of deaths in the posted counts does not address other dimensions of safety. Interpretation would require the event definitions, ascertainment methods, and analysis details, which are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, triple-masked, parallel-group trial of Safety in Dementia was completed and describes its intended primary outcome and assessment schedule. It also identifies the web control as the National Institute on Aging Home Safety Checklist. The central statistical question is whether perceived preparation for decision-making differed between the assigned groups, and with what precision. The record does not report the estimates needed to answer that question.
Preparation for Decision Making is a measure of perceived usefulness of a decision aid in preparing for subsequent decision-making. A score on this measure is not the same as a documented decision, a change in firearm access, or a safety outcome. The registry lists those topics among secondary outcomes, but it does not report their results. Consequently, the outcome description cannot be used to infer what participants decided or what happened after participation.
Likewise, a completed study status does not mean that its findings are available in the registry. Without a group comparison, the record does not support a statement that scores were higher or lower in either group, nor an assessment of how uncertain any difference might be. General descriptions of the scale’s reliability and scoring do not substitute for trial-specific outcome data.
The adverse-event entries provide counts, but not enough detail to establish comparative safety or attribution. They should be understood separately from the unreported primary outcome and from the unreported secondary outcome results. The registry record offers information about what the trial set out to measure, not a full account of what the trial found.
Accordingly, the statistical interpretation is limited: the trial design and measurement framework are described, while the results needed to quantify the primary treatment contrast are not reported in the registry record. Any conclusion about efficacy, effect size, or precision would go beyond the posted information.
13. Why This Trial Matters Statistically
This trial is statistically notable because its primary outcome concerns perceived preparation for a decision, rather than a simple clinical event. Such measures can be suitable for evaluating an intervention intended to support decision-making, but their interpretation depends on clear scoring, timing, and analysis. The registry describes the score’s construction and range, and specifies repeated assessments after randomization. It does not report how those repeated observations were incorporated into an analysis.
The design also highlights why a registry description and a results record answer different questions. Randomization and masking describe features intended to support a fair comparison, while outcome estimates and uncertainty quantify what was observed. Here, the design is recorded, but the primary comparison is not. The completed status cannot fill that evidence gap.
More broadly, this record illustrates the importance of identifying the estimand: the precise group contrast, outcome, assessment time, and analysis population that a result is meant to represent. The registry identifies the outcome and several assessment times, but does not state a single primary comparison or analysis population. Those omissions make it difficult to determine what result would have been the main answer to the trial’s statistical question.
The posted adverse-event counts add descriptive information but likewise require context before comparative interpretation. Definitions, ascertainment, and analysis methods are needed to understand what event counts represent. Taken together, the record shows why transparent reporting of results, analysis choices, and missing-data handling is essential for interpreting a completed trial.
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 statistical interpretation is that the registry record does not report the primary outcome results. It gives no group means, effect estimate, confidence interval, or p-value for Preparation for Decision Making. It also provides no outcome results for the listed secondary measures. As a result, the intervention’s measured effect and its precision cannot be assessed from the registry record.
The outcome is scheduled at baseline after randomization allocation, 2 weeks, 2 months, and 6 months, but the record does not identify which time point or combination of time points defines the primary comparison. It does not report whether the analysis used follow-up scores, change from baseline, or a repeated-measures model. These details affect the interpretation of any estimated effect.
The record reports that 492 participants had a primary outcome score at at least one time point, but does not give assessment-specific completion counts or reasons for missing observations. It also does not describe an analysis population or missing-data method. The record lists a triple-masked design but does not specify who was masked or how masking was maintained. Randomization sequence generation and allocation concealment procedures are also not reported in the registry record.
For safety, the registry gives counts and participants at risk but does not define the event-counting approach, report event-level detail, or provide a comparative analysis. The meaning and denominator of the listed 4.4% serious-event term are not specified. Finally, the registry does not report the trial’s sample-size justification, statistical analysis plan, or multiplicity approach. These are reporting limitations; they do not establish how the trial was conducted beyond what the registry record states.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: "Safety in Dementia": An Online Caregiver Intervention — NCT05173922.
- Registry record last updated 2026-05-14; status last verified 2026-05.
- Results first posted 2026-05-14.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes NCT05173922, Safety in Dementia: An Online Caregiver Intervention, as a completed randomized, triple-masked, parallel-group behavioral trial with enrollment of 500. Recruitment was intended for informal caregivers of community-dwelling adults with dementia who have firearm access. The intervention was an online tool about decisions related to firearm access; the web control viewed the National Institute on Aging Home Safety Checklist.
The primary outcome was Preparation for Decision Making, assessed at baseline after randomization allocation, 2 weeks, 2 months, and 6 months. The record reports that 492 participants had a score at at least one time point. It does not report primary or secondary outcome analyses, effect estimates, or uncertainty intervals. Serious and other adverse-event counts are listed by group, along with no deaths in either group, but the record does not provide a comparative safety analysis or event-level context.