Faith-Based Toolbox for African Americans With Dementia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Faith-Based Toolbox for African Americans With Dementia (NCT04325204), a non-randomized na study. The primary outcome is Number of Participants Recruited Within the Goal of 12 Months.

2. Clinical Question

The study’s stated purpose was to create and test faith-based activities that might be useful for African American adults with moderate and severe dementia and their caregivers. Its primary endpoint focuses on the time needed to recruit participants, rather than on a clinical change in dementia symptoms, caregiver well-being, or another health outcome. The registry describes recruitment as feasible if enrollment could be completed within 12 months, with a target pace of 2 to 3 dyads per month.

The registry also lists caregiver heart rate variability in time and frequency domains, and caregiver skin conductance level, among the secondary outcomes. These outcomes concern physiological measures, but their results are not reported in the registry record. The primary result is also not reported. Therefore, the registry record does not establish how long recruitment took relative to the goal or what changes, if any, were observed in the secondary outcomes.

3. Trial Design

This was a completed, non-randomized, parallel study sponsored by Emory University. The registry lists Alzheimer disease and dementia as the conditions studied. Enrollment is recorded as 54. The study began on 2021-08-19, and primary completion is recorded as 2023-07-13. The trial phase is listed as NA, and masking is listed as none.

The intervention was the Faith-Based Home Activity Toolbox (Faith-HAT), classified as behavioral. Both caregivers and persons living with dementia participated in the intervention for 6 weeks. The study aimed to enroll 30 dyads, where a dyad consists of a person living with dementia and a family caregiver. The enrollment figure in the registry and the recruitment aim are different kinds of information: one is the recorded enrollment, while the other describes the stated target. The primary outcome result does not report whether the recruitment goal was achieved within the planned timeframe.

The registry describes a parallel model, but it does not identify a separate control group or a randomized assignment. The two listed groups are caregivers and persons living with dementia participating in Faith-HAT. They have different roles and are not a like-for-like treatment comparison. Consequently, differences between those groups would not serve as a randomized estimate of intervention effect.

The registry record does not report the recruitment approach, eligibility criteria beyond the population described, intervention delivery details, adherence, or a statistical analysis plan. These design details should not be inferred from the intervention name or the stated study purpose.

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 Number of Participants Recruited Within the Goal of 12 Months, measured over At enrollment (up to 21 months of study).

The primary endpoint is titled “Number of Participants Recruited Within the Goal of 12 Months.” Its unit is participants, and its timeframe is at enrollment, up to 21 months of study. The registry’s description frames feasibility in terms of how many months recruitment took and states that the researchers aimed to finish recruitment within 12 months, enrolling 2 to 3 dyads per month.

This endpoint addresses whether a study can recruit its intended participants on a practical schedule. Recruitment feasibility is useful when assessing whether a larger or later study could be conducted with the target population. It is a process measure, not a measure of treatment benefit, symptom change, or safety.

The registry record does not report the observed number recruited within the goal period or the time taken to complete recruitment. It also does not explain how recruitment within the goal was operationalized in the reported outcome, beyond the description of the 12-month aim and the intended monthly pace. Without the endpoint result, it is not possible to determine from the registry whether the stated recruitment target was met.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies the primary outcome as a count of participants recruited within a recruitment goal. It does not report an analysis method, an estimate for that endpoint, or an associated measure of precision. The registry lists 0 analyses. Accordingly, statistical interpretation must distinguish the stated outcome definition from results that are not reported in the registry record.

What does a count endpoint describe?

A count records how many participants meet a defined condition. In this study, the condition concerns recruitment within the stated 12-month goal. Counts can be useful for describing whether a recruitment milestone was reached, but a count alone does not explain how recruitment proceeded over time. The registry describes the intended pace as 2 to 3 dyads per month and gives a timeframe of at enrollment, up to 21 months of study. It does not report the observed count within the goal or the elapsed recruitment time.

General: a count may be analyzed using methods suited to count data, but the choice depends on the outcome definition, the study design, and the distribution of observations. Over-dispersion is a general statistical concern when count variability exceeds what a chosen model expects. If present, it can make uncertainty estimates from an unsuitable model too small. The registry does not report a count model, a dispersion assessment, or any other statistical method, so it is not possible to say whether these considerations were assessed.

What would a confidence interval add?

General: a confidence interval expresses uncertainty around an estimate under a statistical model and its assumptions. It can help readers judge whether a result is precise enough to distinguish among plausible values. The registry record does not report a confidence interval for recruitment or for the listed secondary outcomes. Without an estimate and its uncertainty, the degree of precision cannot be evaluated.

General: a p-value is calculated relative to a statistical model and a specified null hypothesis. It does not measure the probability that the null hypothesis is true, and it does not give the size of an effect. The registry reports 0 analyses and no p-values. No hypothesis test or testing procedure should therefore be attributed to this study based on the registry record.

How should sample-size illustrations be understood?

A sample-size illustration based on an observed effect is not the same as the trial’s original design justification. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that the study had a particular power for its actual design. The record does not report a sample-size justification for this trial, and the intervention groups are not a randomized, like-for-like comparison. Any illustration based on an observed effect should be treated as hypothetical planning, not as observed power or as a trial result.

General: power is a design-stage probability tied to a specified effect, variability, sample size, and analysis plan. It cannot establish whether an observed result is true or important. A calculation based on an effect observed in the same study is especially different from a prospective design justification, because it uses information from the results rather than solely prespecified assumptions. Since the registry does not report the relevant observed primary effect or analysis, no particular planning illustration can be interpreted as a direct test of the recruitment endpoint.

What can be said about the design?

The study is listed as non-randomized, unmasked, and parallel. General: random assignment can help balance measured and unmeasured participant characteristics between treatment groups, while masking can reduce some forms of assessment or behavior-related bias. Neither feature is reported for this study. The two described participant groups—caregivers and persons living with dementia—also differ in role, so their outcomes should not be interpreted as a controlled treatment contrast. The registry does not report an adjusted or unadjusted analysis, an analysis population, or a method for handling repeated measurements.

The secondary outcomes are physiological measures for caregivers: heart rate variability in time and frequency domains, and skin conductance level. Their inclusion does not indicate what statistical tests were used or whether changes were observed. Results, analysis methods, and precision measures for these endpoints are not reported in the registry record. General statistical concepts can clarify what such methods would mean, but they cannot fill in an unreported analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 outcome measures and 0 analyses. It identifies the recruitment count as the primary outcome and lists caregiver heart rate variability in time and frequency domains and caregiver skin conductance level as secondary outcomes. The registry record does not report how many outcomes were formally analyzed, whether any hypothesis tests were performed, or whether a multiplicity adjustment was planned or used.

General: when several outcomes or hypotheses are tested, the chance of obtaining at least one apparently notable result by chance can increase. Statistical plans may address this through a prespecified hierarchy, adjustment procedures, or a clear distinction between primary and exploratory outcomes. The registry does not describe such a plan, so readers cannot determine how multiplicity was handled. The listing of several outcomes alone does not establish that tests were conducted.

Missing-data methods and the amount of missing outcome data are not reported in the registry record. The record also does not describe analysis populations, such as which participants were included in each outcome analysis or how incomplete observations were treated. General: missingness can affect an estimate if the availability of data is related to participant characteristics or outcomes. Methods for handling missing observations depend on the design and the reasons data are absent; none should be assumed for this study.

The record does not report an analysis plan or interim analyses. It is therefore not possible to assess whether outcome definitions and analysis decisions were prespecified, or whether any changes were made during the study. These are limitations of what can be interpreted from the registry record, not evidence that a particular procedure was or was not followed outside the information recorded there.

11. 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 separate safety groups for caregivers and persons living with dementia, with 27 participants at risk in each group. For caregivers, the record reports 0 serious adverse events, 0 other adverse events, and 0 deaths. For persons living with dementia, it reports 0 serious adverse events, 0 other adverse events, and 1 death.

These are descriptive counts. The registry record does not report event narratives, timing, severity details beyond the serious-event classification, or an assessment of whether an event was related to Faith-HAT. The single recorded death should not be attributed to the intervention based on this information alone. Likewise, zero reported serious or other adverse events does not establish that no events occurred outside the recorded categories or observation period.

General: safety counts are interpreted in the context of how events were defined, collected, and followed, and whether there is a suitable comparison group. Because this study is non-randomized and the two groups are not like-for-like control arms, these figures do not provide a randomized comparison of safety. The registry record does not report the methods used for adverse-event collection or the duration of safety follow-up.

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

The registry record establishes that this completed study tested a behavioral faith-based toolbox with caregivers and persons living with moderate or severe dementia, and that recruitment feasibility was the primary outcome. It records enrollment of 54 and describes an aim to enroll 30 dyads. The study’s primary outcome was intended to measure recruitment within the goal of 12 months, with an intended pace of 2 to 3 dyads per month.

However, the registry does not report the primary endpoint result. It therefore does not show whether the recruitment goal was met or how quickly participants were recruited. The registry also does not report results for the listed physiological secondary outcomes, nor does it report statistical analyses or estimates of effect. A conclusion about the magnitude, direction, or precision of any change in those measures would go beyond the recorded information.

The design also does not support a direct treatment-versus-control interpretation from the caregiver and dementia-participant groups. Both groups participated in Faith-HAT, and their roles differ. The registry does not describe a separate control intervention or random assignment. Changes observed in either group, if reported elsewhere, would need to be interpreted in light of these design features and any analysis details.

General: a study’s stated aim is not the same as a demonstrated result. A feasibility target can guide planning, but it does not establish that a later study will recruit at the same pace. Likewise, an intervention being tested does not by itself establish benefit or lack of benefit. The available record supports a description of the study design and outcome framework, but not a conclusion about intervention effectiveness or the success of the recruitment target.

The safety entries are also limited to recorded counts. They do not establish causation, comparative risk, or the absence of unrecorded events. Overall, the most important interpretive point is that the registry supplies design information and safety counts but does not report the primary outcome result or statistical analyses needed to answer the study’s main feasibility question.

13. Why This Trial Matters Statistically

This study is statistically notable because its primary question is about recruitment feasibility rather than a clinical treatment contrast. For research involving a population that includes people living with moderate and severe dementia and their family caregivers, the ability to recruit dyads on a planned schedule can be an important practical issue. The stated recruitment goal—completion within 12 months, at a pace of 2 to 3 dyads per month—makes that process question explicit.

The endpoint also illustrates why outcome definitions and results need to be considered together. A count of recruited participants can communicate progress toward a target, while the time taken to recruit gives context for whether that target was achieved on schedule. The registry describes both the intended pace and the endpoint timeframe, but does not report the result that would allow the feasibility question to be assessed.

The study is non-randomized and has no separate control intervention identified. That distinction matters because the caregiver and dementia-participant groups are not equivalent comparison arms. Describing the intervention and its participants is possible; estimating a causal intervention effect from a like-for-like comparison is not supported by the registry design information.

The record also names physiological outcomes for caregivers, which could be relevant to an evaluation of the intervention, but it does not report their findings or analyses. Reporting estimates with measures of uncertainty and a clear analysis plan would be necessary for readers to assess the scale and precision of any observed changes. With 0 analyses listed, those statistical conclusions cannot be drawn from the registry record.

Finally, the safety counts demonstrate why event counts need context: group definitions, follow-up, event ascertainment, and causal assessment all affect interpretation. The record gives basic counts but not those details. The study is therefore informative as a registered feasibility-oriented intervention study, while the absent outcome analyses sharply limit conclusions about recruitment performance, physiological outcomes, and safety.

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 most direct limitation for interpretation is that the registry record does not report the primary recruitment result. Although it gives the intended recruitment goal and timeframe, it does not state the observed number recruited within the goal or the time required to complete recruitment. The central feasibility endpoint therefore cannot be evaluated from the posted results.

The record lists 0 analyses, and results for the secondary physiological outcomes are not reported. There are no effect estimates, confidence intervals, or p-values with which to assess magnitude or precision. The registry also does not report a statistical analysis plan, sample-size justification, interim analyses, analysis populations, or methods for missing data and multiplicity.

The non-randomized design has no separate control intervention identified. The caregiver and dementia-participant groups differ in role and are not a like-for-like comparison. The registry also lists no masking. These design features constrain causal interpretation and make it inappropriate to treat the groups as randomized intervention and control arms.

Other details relevant to interpreting recruitment and outcomes are not reported in the registry record, including recruitment procedures, intervention delivery and adherence, outcome-assessment procedures, and the duration and methods of safety follow-up. The stated target of 30 dyads should not be confused with the recorded enrollment of 54, nor does either figure alone show whether the primary recruitment goal was met within 12 months.

The safety entries are counts without event descriptions or causal assessments. They should not be interpreted as comparative safety estimates. These limitations reflect the information recorded in the registry and do not establish what may have been collected or analyzed outside that record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Faith-Based Toolbox for African Americans With Dementia — NCT04325204.
• Registry record last updated 2024-10-08; status last verified 2024-09.
• Results first posted 2024-10-08.
• 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

NCT04325204, titled “Faith-Based Toolbox for African Americans With Dementia,” is a completed, non-randomized, unmasked, parallel study sponsored by Emory University. The registry lists Alzheimer disease and dementia as conditions and records enrollment of 54. The study began on 2021-08-19, with primary completion on 2023-07-13.

The behavioral intervention was the Faith-Based Home Activity Toolbox (Faith-HAT). Caregivers and persons living with dementia participated for 6 weeks. The study aimed to enroll 30 dyads. Its primary outcome concerns the number of participants recruited within a goal of 12 months, with recruitment described as a feasibility measure and an intended pace of 2 to 3 dyads per month.

The registry lists 11 outcome measures and 0 analyses. The primary outcome result and secondary physiological outcome results are not reported in the registry record. Safety entries list 0 serious adverse events and 0 other adverse events in both groups, with 0 deaths among caregivers and 1 death among persons living with dementia. The record does not provide causal assessments for these events.