Technology and Family Thriving Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Technology and Family Thriving Study (NCT05150990), a randomized na study. The primary outcome is Quality of Life in Alzheimer's Disease (QOL-AD) - Changes From Baseline (Older Adult).

2. Clinical Question

The study also concerned family relationships and several aspects of technology sessions, including affect, social and conversational engagement, relationship satisfaction, communication quality, and telepresence. These are distinct from the primary question about older adults’ QOL-AD scores. The registry lists cognitive impairment level as a factor of interest, but does not report numerical findings about that factor or about the primary comparison.

3. Trial Design

The Technology and Family Thriving Study is recorded as a randomized, parallel-group trial with no masking. Its enrollment is 186. The two behavioral interventions were weekly activities using virtual reality (Rendever) and weekly activities using video conference (Zoom). The trial status is completed. The registry lists the study start as 2021-10-02 and primary completion as 2024-03-16. The phase is listed as not applicable.

The study concerns older adults with cognitive impairments living in senior living communities and an adult child living at a distance. Its stated purpose was to test the impact of virtual reality compared with video chat on quality of life and family relationships. It also aimed to investigate whether responses to technology and quality-of-life outcomes depended on the older adults’ level of cognitive impairment. The sponsor is the University of California, Santa Barbara.

A parallel design assigns participants to one intervention group or the other, with the groups followed over the study period. Randomization can support a fair comparison by reducing systematic differences between groups, although the registry record does not describe the allocation procedure or whether assignment was concealed. No masking was used, so participants and study personnel were not masked according to the registry classification. The record does not report the protocol details needed to determine how activities were delivered, monitored, or adapted beyond the descriptions of weekly activities.

The primary outcome description identifies baseline at T1, one week before the intervention, and the primary follow-up at T2, one week after the intervention. T3, one month after the intervention, and T4, three months after the intervention, are described as exploratory in the primary outcome entry. Numerical primary-outcome results are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Some participants withdrew from the study after the T1 (baseline) assessment. Several others remained in the study but failed to complete the T2 (post-intervention) assessment. Primary aims focus on changes from T1 (Baseline) to T2 (1-week Post-Intervention). T3 and T4 are exploratory and not presented here.

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.

Population: A total of 186 dyads (372 individuals) enrolled and completed a brief intake survey on demographics and health. Of these, 96 dyads (N=193) were assigned to the Video Chat arm and 90 (N=180) to the Virtual Reality arm. The intake survey was completed at enrollment; the full baseline survey occurred later, after some dyads withdrew. Thus, the number of baseline cases may vary slightly depending on the source of the variable being reported (intake vs. full baseline survey).

6. Primary Endpoint

The registry lists the primary outcome as Quality of Life in Alzheimer's Disease (QOL-AD) - Changes From Baseline (Older Adult), measured over T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention).

The primary endpoint is change from baseline in older adults’ Quality of Life in Alzheimer’s Disease score, or QOL-AD. It is a 13-item self-report measure completed by older adult participants. Each item is rated on a 4-point scale, from 1 for Poor to 4 for Excellent. The total score is the mean of all items and ranges from 1 to 4; higher scores indicate greater quality of life. The main time comparison is T1, baseline one week before the intervention, to T2, one week after the intervention.

Quality of life is relevant to this study because its stated aim concerns how different forms of technology relate to quality of life in older adults living in senior communities. The endpoint captures participants’ own reported assessments rather than a measure of family members’ perceptions. Adult children also reported on their parents’ quality of life as a secondary outcome, according to the endpoint description; that is a separate perspective and should not be confused with the primary older-adult self-report.

For interpreting a mean score, the direction of the scale matters: higher QOL-AD scores indicate greater reported quality of life. The registry record does not report the group means, standard deviations, or numerical changes needed to describe the observed primary outcome. It therefore does not establish from the posted results how scores changed or how precisely any difference between groups was estimated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registered primary measure is continuous: it is a score on a scale summarized using a mean and standard deviation. The stated primary aim focuses on change from T1 to T2, with T3 and T4 described as exploratory. The registry record does not provide the numerical outcome summaries or a statistical analysis plan, so the methods below explain how such quantities are generally interpreted without asserting which analyses were used for this trial.

What does a mean score describe?

In general, a mean describes the central level of a measured outcome across the observations included in an analysis. For QOL-AD, the score is the mean of the 13 item ratings for an older adult. A group mean would then summarize scores for the participants contributing data to that group and time point. The standard deviation describes how dispersed individual scores are around the group mean. Neither measure, by itself, shows whether one group changed more than the other.

Because the endpoint is on a bounded 1-to-4 scale, interpretation should remain tied to the scale’s stated meaning: higher values indicate greater quality of life. A mean change is an average change, not a statement that every participant changed by that amount. Individual responses can vary around the group summary. The record does not provide group means or standard deviations at T1 or T2, so no such values or changes can be described for this trial.

Why distinguish within-group change from a group comparison?

In general, a before-and-after change within one group describes how scores differ across time for participants in that group. A comparison between randomized groups asks whether their changes differ, or whether their outcome levels differ under a specified analysis. These are not interchangeable questions. A change within one arm alone does not quantify the comparative effect of virtual reality versus video chat. For this study, the primary aims are described as changes from T1 to T2, but the registry record does not report the model or contrast used to compare groups.

Repeated measurements from one participant are related rather than independent observations. In general, an analysis of repeated measurements needs to account for that relationship, or use a clearly defined change score or other prespecified approach. Different valid analysis choices can produce estimates with different interpretations. The analysis method, handling of repeated observations, covariates, and any adjustment for baseline score are not reported in the registry record. It would therefore be inappropriate to attribute a particular model to the study.

What does a confidence interval add?

In general, a confidence interval expresses statistical uncertainty around an estimate. A narrow interval indicates greater precision than a wide interval, given the model and assumptions used; it is not a guarantee that the true value lies within a particular interval. An interval can also help readers assess which effect sizes are compatible with the data, rather than relying only on whether a p-value crosses a threshold. No primary-outcome confidence interval is reported in the registry record, so precision cannot be evaluated for the main comparison.

A p-value, in general, measures how incompatible the observed data are with a specified null hypothesis under the assumptions of a statistical test. It does not measure the probability that the null hypothesis is true, the size of an effect, or its practical importance. No primary-outcome p-value is reported in the registry record. Statistical significance, if reported elsewhere, would need to be considered alongside the estimate, its uncertainty, the outcome scale, and the analysis plan.

How should missing observations be considered?

The endpoint entry reports that some participants withdrew after baseline and several others did not complete the post-intervention T2 assessment. In general, missing outcome data can affect an estimate when the people with observed scores differ systematically from those without scores. The potential impact depends on why data are missing, how much is missing in each group, and what assumptions an analysis makes. The registry record does not report the numbers missing by group, reasons for missingness, or methods used to handle missing outcomes. No particular missing-data assumption or procedure can therefore be attributed to this trial.

For complete interpretation, readers would ordinarily look for the number randomized and analyzed in each group, the outcome summaries at relevant time points, an explicit between-group estimate with uncertainty, and a description of the analysis population and missing-data handling. Those primary-outcome details are not reported in the registry record. The listed enrollment and study design do not substitute for these results.

What do planning illustrations mean?

In general, a sample-size planning illustration estimates how many participants per arm would be needed to detect an assumed effect at a chosen significance level and power under specified assumptions. It is not the number of participants observed in the trial and is not observed power. The registry record describes its planning illustrations as based on a fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. These are planning assumptions, not evidence that the trial was originally designed using those assumptions. The trial’s own sample-size justification is not reported in the registry record.

Planning estimates depend on the effect size used and on assumptions about variability, allocation, and the analysis. They should not be read as a substitute for an observed treatment-effect estimate or confidence interval. The registry record does not report primary-outcome results needed to explain an observed contrast in numerical terms. Consequently, the planning assumptions can be described, but they cannot establish the observed precision or findings of the trial.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 24 outcome measures, spanning the primary QOL-AD outcome and other outcomes concerning technology sessions and family relationships. The primary outcome entry identifies the T1-to-T2 change as the main focus and describes T3 and T4 as exploratory. The registry record does not report a multiplicity plan, such as which outcomes or time points were designated for formal confirmatory testing or whether any adjustment for multiple comparisons was planned. The presence of many measures does not, by itself, establish that each was tested or that a particular correction was used.

The record lists zero analyses, and numerical results for the primary outcome are not reported in the registry record. This prevents assessment of how many comparisons produced results, how they were selected, or whether the analysis followed a prespecified hierarchy. The statistical analysis plan and any interim analyses are not reported in the registry record.

Missingness is specifically noted for the primary outcome: some participants withdrew after T1 baseline, and several participants who remained in the study did not complete the T2 post-intervention assessment. The numbers and reasons are not reported in the registry record. Group-specific completion counts, the population included in the primary analysis, and the handling of missing observations are also not reported. In general, these details matter because an analysis using only participants with complete measurements can have a different interpretation from one using another approach, particularly if missingness is related to outcomes or group assignment.

The registry identifies random allocation but does not report the analysis population definition or whether all randomized participants were included in the primary analysis. It is therefore not possible to characterize the reported primary result as intention-to-treat, per-protocol, or another population-based analysis. No such label or procedure should be inferred from the study design alone.

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.

Most frequent non-serious adverse event terms

The registry lists serious adverse events for the Video Chat group among 96 participants at risk: 0 were affected. For the Virtual Reality group, 0 of 90 participants at risk were affected by serious adverse events. The record lists no top serious-event terms, so the types of serious events are not described there.

Other adverse events are listed for 3 of 96 participants at risk in the Video Chat group and 2 of 90 participants at risk in the Virtual Reality group. Deaths are listed separately as 2 in each group. These are registry counts and should not be combined or reclassified without further information about the reporting definitions. The record does not report event descriptions, timing, severity details beyond the categories shown, or whether events were judged related to an intervention.

In general, adverse-event counts describe what was recorded, not necessarily what was caused by an intervention. Comparisons based on small counts are also uncertain and should be interpreted with the reporting context in mind. The registry entries do not provide enough detail to determine the circumstances of the events or to make a causal assessment.

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

The registry record establishes that this completed study randomized older adults with cognitive impairments in senior living communities to weekly virtual reality activities using Rendever or weekly video-conference activities using Zoom. It identifies older adults’ QOL-AD change from baseline to one week after the intervention as the primary focus. It also describes interest in family relationships and whether responses might depend on cognitive impairment level.

Those design details do not reveal what happened to QOL-AD scores. Numerical primary-outcome findings are not reported in the registry record, and no between-group estimate or confidence interval is available in the record. It is therefore not possible to describe the direction, size, or precision of a comparative effect from these registry entries. A completed study status is not itself a result.

The endpoint is a self-report scale with scores from 1 to 4, where higher scores indicate greater quality of life. Its measurement provides an outcome framework, not proof of a particular change. Likewise, the registry’s mention of adult-child reports as a secondary outcome does not make those reports interchangeable with older adults’ self-reports. The record does not report numerical results for either perspective.

The same distinction applies to safety. The registry lists serious adverse events affecting zero participants in each group and lists other adverse events and deaths separately. These counts do not establish whether any event was caused by an intervention or explain its clinical circumstances. More detailed event information is not reported in the registry record.

In general, an effect estimate is most informative when considered with its uncertainty, outcome definition, missing-data context, and analysis plan. Those elements are not sufficiently reported for the primary comparison in this registry record. The posted information therefore describes the trial question, design, endpoint, and selected safety counts, but it cannot support a conclusion about the comparative primary-outcome result.

13. Why This Trial Matters Statistically

This study raises a question that requires careful measurement: whether different forms of technology are associated with changes in quality of life for older adults with cognitive impairments, while also considering family relationships and the experiences of adult children at a distance. The primary endpoint is based on older adults’ own QOL-AD reports, which distinguishes that perspective from adult-child ratings listed as secondary.

Statistically, the design makes the comparison between randomized groups central. A within-group change and a difference between groups answer different questions, and the primary result would need to be interpreted using an explicit estimate and its uncertainty. The registry describes a baseline assessment, a primary post-intervention time point, and later exploratory assessments. That structure makes the choice of time point and analysis important, especially when measurements are repeated and some participants do not contribute a T2 assessment.

The registry record also highlights issues common to studies with multiple outcomes: the outcome list is broad, while the analysis plan and multiplicity approach are not reported. Without those details and numerical results, readers cannot determine how the primary finding was estimated or how it should be distinguished from exploratory comparisons. The listed enrollment does not tell readers how many participants contributed primary endpoint data.

These considerations matter because a study’s design and intended measures can be described even when its results are unavailable in the registry record. Separating what is known about the design from what is not reported about the analysis and outcomes prevents overstatement. In this case, the registry supports understanding the comparison and measurement strategy, but not an empirical claim about which group had greater change or how precise that comparison was.

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 registry record does not report numerical results for the primary QOL-AD outcome, including group summaries, changes, a comparative estimate, confidence intervals, or p-values. The analysis plan, including the model used for repeated measurements and any adjustment for baseline values, is not reported. These gaps prevent evaluation of the size and precision of the primary comparison.

Missing primary-outcome data are acknowledged: some participants withdrew after T1, and several participants who remained did not complete T2. The numbers, reasons, and distribution by group are not reported in the registry record. The approach to missing data and the primary analysis population are also not reported, limiting assessment of potential bias from incomplete follow-up.

The study is listed as randomized and unmasked, but implementation details about sequence generation, concealment, and intervention delivery are not reported in the registry record. The primary endpoint is self-reported by older adults; adult-child reports are identified separately as a secondary outcome. The registry record does not provide the numerical findings for either perspective or clarify the extent to which outcome collection was complete.

The record lists 24 outcome measures but does not report a multiplicity strategy or analysis results. T3 and T4 are described as exploratory in the primary outcome entry, but their findings are not reported in the registry record. Safety information is limited to event counts and does not include event descriptions or attribution. These limitations concern the information available in the registry record and do not establish what may be available in other study materials.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Technology and Family Thriving Study — NCT05150990.
• Registry record last updated 2026-07-29; status last verified 2026-07.
• Results first posted 2025-07-15.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The Technology and Family Thriving Study is a completed, randomized, parallel-group study sponsored by the University of California, Santa Barbara, with enrollment of 186 and no masking listed. It compared weekly virtual reality activities using Rendever with weekly video-conference activities using Zoom for older adults with cognitive impairments in senior living communities and adult children living at a distance.

The primary outcome is older adults’ QOL-AD score, with the main focus on change from T1 baseline to T2 one week after the intervention. T3 at one month and T4 at three months are described as exploratory. The registry notes withdrawal after baseline and incomplete T2 assessments for some participants. Numerical primary-outcome results, analysis methods, and missing-data procedures are not reported in the registry record. The safety entries list no serious adverse events affecting participants in either group, alongside separate counts for other adverse events and deaths.