A Study of Mobile Medical Supportive Care Program for Family Caregivers With Dementia Combined With Diabetes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of Mobile Medical Supportive Care Program for Family Caregivers With Dementia Combined With Diabetes (NCT06785857), a randomized na study. The primary outcome is Caregiver Burden Inventory- Baseline (Month 0).

2. Clinical Question

The trial’s stated purpose was to evaluate a mobile medical supportive care program for family caregivers in the context of dementia and diabetes. The practical comparison is between the mobile program added to monthly home visits and offline supportive care. The registry describes the study as randomized and parallel-group, but the posted primary endpoint is “Caregiver Burden Inventory- Baseline (Month 0),” with a baseline, pre-intervention timeframe.

This distinction matters when interpreting the clinical question. A randomized comparison can assess intervention effects when outcomes are measured after intervention and analyzed in a way that compares groups or change over time. A baseline measure instead characterizes starting status. The registry record does not post a primary caregiver-burden result at a post-intervention time point, nor does it report an analysis comparing post-intervention burden between groups.

Social support and dementia-care knowledge are also listed as secondary outcomes, including baseline and post-intervention measures. The posted results include a baseline social-support comparison, but post-intervention values and analyses are not reported in the registry record. The available information therefore identifies the intervention and intended outcome domains, but does not establish the effect of the program on caregiver burden, social support, or caregiving knowledge.

3. Trial Design

The registry identifies this as a randomized, single-masked, parallel-group trial. “Single-masked” is recorded, but which participants or study personnel were masked is not reported in the registry record. The study status is completed, with enrollment of 60. The recorded start date is 2022-05-01 and primary completion date is 2022-09-01.

The two groups received different supportive care approaches. The offline group received routine community public-health services for chronic diseases, with diabetes and dementia health education for caregivers during monthly home visits. The mobile group received the monthly home visits described for the comparison group, with a mobile supportive care program added through “Xiamen iHealth.” Its description refers to weekly mHealth support, one supportive care item every two weeks for 12 weeks, a total of 12 online interventions, and online consultations. Further operational detail is not reported in the registry record.

The posted baseline caregiver-burden results include 27 participants in the offline group and 28 in the mobile group. These group counts do not account for all 60 enrolled participants; how the remaining enrollment relates to the posted outcome data is not reported in the registry record. The primary measure’s population description refers to withdrawal due to the death of the care recipient, but the record does not explain how that circumstance was handled in the analysis.

Although the study is marked completed, the number of reported analyses is zero. The registry lists six outcome measures and four posted secondary outcomes, but only baseline caregiver burden and baseline social-support values are accompanied by group results in the available record. Randomization details, allocation concealment, protocol deviations, the analysis population, and the statistical analysis plan 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: The total enrollment number (N=60) refers to individual caregivers (not patient-caregiver dyads). Collected only for caregivers (e.g., demographics, Caregiver Burden Inventory \[CBI\], Social Support Rating Scale \[SSRS\]). Patient data (e.g., diagnosis confirmation) were used only for screening. All outcomes (e.g., caregiver burden, knowledge, social support) are caregiver-centered. No patient health outcomes are measured.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Withdrawal due to the death of the care recipient.

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: Family caregivers was randomly allocated in a strict 1:1 ratio at baseline, with 30 carers in each of the intervention and control groups (60 cases in total). During the course of the intervention, 2 carers in the intervention group withdrew from the study due to the death of the care recipient (patient) and 3 in the control group withdrew for the same reason. Therefore, the final number of participants who completed the analysis was 28 in the intervention group and 27 in the control group.

6. Primary Endpoint

The registry lists the primary outcome as Caregiver Burden Inventory- Baseline (Month 0), measured over Baseline (pre-intervention).

The named primary measure is the Caregiver Burden Inventory (CBI) at baseline, before intervention. The record describes a Chinese-language version adapted for mainland China and states that the CBI was initially used to measure the burden experienced by caregivers of people with dementia. Its domains include physical burden, emotional burden, social burden, time-dependent burden, and developmentally limited burden.

Each item uses a Likert scale from strongly agree (4) to strongly disagree (0), and total scores range from 0 to 96. Higher scores indicate greater caregiver burden. The description states that a score of ≥ 24 warrants consideration of therapeutic interventions and a score greater than or equal to 36 suggests risk of severe burden. These are scale interpretation thresholds recorded in the outcome description; they are not evidence that a particular intervention is effective.

Caregiver burden is relevant to the trial’s stated focus because the program is intended to support family caregivers. However, the primary endpoint is explicitly listed at baseline (Month 0), rather than after the intervention. The posted group medians are 56.0 for offline supportive care and 57.0 for the mobile program, with inter-quartile ranges of 53.0 to 60.0 and 54.0 to 60.75, respectively. These values describe starting burden in the participants with posted results. They cannot show whether burden changed during the program or whether any change differed between groups. A post-intervention primary caregiver-burden result is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry records random assignment and a parallel-group design. In a parallel trial, participants are assigned to one group and receive that group’s intervention approach; the record identifies offline supportive care as the comparator and the mobile supportive care program as the intervention. Randomization is intended, in general, to reduce systematic differences between groups at assignment. Its success cannot be assessed from a single endpoint summary, and details of sequence generation and allocation concealment are not reported in the registry record.

What does the baseline primary measure tell us?

The primary measure is the CBI at baseline, summarized as a median and inter-quartile range. A median is the middle value when observations are ordered. The inter-quartile range describes the middle half of the observed values, from the 25th to the 75th percentile. These summaries can be useful when a score distribution is skewed or when a typical value and spread are more informative than a mean and standard deviation. They describe the distribution at entry; without a later measurement and an appropriate comparison, they do not quantify change attributable to an intervention.

The CBI score ranges from 0 to 96, and the outcome description says higher scores indicate greater burden. The group medians and inter-quartile ranges are baseline descriptions. The registry does not report a post-intervention CBI value, a change score, or a between-group treatment-effect analysis for this outcome. A threshold described in the scale definition can aid interpretation of a score, but it does not replace a randomized comparison of outcomes after treatment.

How should the baseline social-support comparison be read?

The social-support baseline result is summarized using means and standard deviations and includes an unadjusted mean difference, confidence interval, and p-value. A mean is the arithmetic average; a standard deviation describes dispersion around that average. The reported mean difference is 0.6, with a confidence interval from -0.652 to 1.852. This comparison is between groups before intervention, so it describes baseline data rather than an intervention effect.

In general, a confidence interval gives a range of estimates compatible with the observed data and the method’s assumptions. Its width reflects precision: wider intervals indicate greater uncertainty about the estimate. A p-value is not the probability that the null hypothesis is true, nor does it measure the size or importance of an effect. The unadjusted p-value of 0.348 is reported for this baseline comparison. The registry does not state an adjustment for multiple comparisons or give a detailed testing plan.

What do the planning illustrations mean?

The sample-size illustrations are explicitly described as planning calculations based on the observed effect, not the trial’s own design. They assume a two-sided significance level of 0.05, equal allocation, and a normal approximation, with effects set to stated fractions of the observed effect. The figures are participants per arm for 80% power and participants per arm for 90% power. They are hypothetical planning quantities, not observed power and not evidence that the trial was designed or powered using those assumptions.

Observed effects can be imprecise, particularly when estimated from limited data. Planning around an observed effect may therefore produce illustrations that do not represent a prespecified clinically important difference. The registry does not report the trial’s sample-size justification, target effect, or power calculation, so the posted planning illustrations should not be treated as the protocol’s rationale.

What is not available for evaluating treatment effects?

The registry lists post-intervention outcomes for social support and dementia-care knowledge, but their results and analyses are not reported in the registry record. The number of reported analyses is zero. The record does not state the planned statistical model, whether baseline adjustment was intended, how missing observations were handled, or which analysis population was used. Interim analyses and stopping rules are also not reported in the registry record.

In general, treatment-effect interpretation depends on the timing of measurement, the comparison being estimated, the analysis population, and assumptions about missing data. Confidence intervals and p-values can quantify uncertainty only for the estimate and model actually used. With baseline summaries alone, no statistical method can establish a post-intervention effect. The registry record therefore supports description of some starting measurements, but not a quantified primary treatment effect.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists several outcome measures, including caregiver burden, social support, and dementia-care knowledge, with baseline and post-intervention time points for some measures. It does not report a statistical analysis plan specifying a primary contrast, a hierarchy of outcomes, or a method for controlling multiplicity. No reported analyses are listed. Without this information, it is not possible to determine which comparisons were prespecified or how the risk of chance findings across multiple outcomes was addressed.

In general, testing many outcomes or time points can increase the chance of at least one apparently unusual result. Adjustment methods or a prespecified hierarchy can help interpret that family of tests. This is particularly relevant for secondary outcomes, which are often exploratory and should not outweigh a well-defined primary result. Here, the available record does not provide post-intervention secondary results or analyses, so multiplicity cannot be evaluated from observed tests.

Missing-data procedures are not reported in the registry record. The primary outcome description refers to withdrawal due to the death of the care recipient, but does not explain how such withdrawal was defined, which participants it affected, or how it was handled statistically. The record posts 27 and 28 participants for the primary baseline summaries, while enrollment is 60; reasons for the difference and the handling of participants without posted outcome values are not reported.

The analysis population is also not reported in the registry record. It is therefore unclear whether the posted data represent all randomized participants, participants with available measurements, or another group. The registry does not describe imputation, sensitivity analyses, protocol deviations, interim analyses, or stopping rules. These omissions limit assessment of selection bias and robustness. They do not establish that any particular method was or was not used outside the information recorded in the registry.

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

The posted results establish that caregiver burden was measured at baseline and that its median was 56.0 in the offline group and 57.0 in the mobile group. They also establish that a baseline social-support comparison was reported, with a mean difference of 0.6 and an unadjusted p-value of 0.348. These findings characterize starting measurements in participants with posted data. They do not establish whether the mobile program changed caregiver burden, social support, or dementia-care knowledge.

The trial is marked completed, but completion status is not itself a result. The record’s intended evaluation of a mobile supportive care program and its reported baseline values should be distinguished from evidence of a treatment effect. A treatment-effect claim would require an outcome measured after the intervention and a suitable comparison, with uncertainty and analysis methods described. The registry does not report a post-intervention primary CBI result or the analyses needed to make that comparison.

In general, a lack of a reported result is not proof that an outcome did not change, and a baseline difference is not proof of benefit or harm. Similarly, the listed deaths cannot be interpreted as comparative safety evidence without information about their definition, timing, attribution, and analysis. The reported planning illustrations are hypothetical calculations and do not describe observed trial power.

The registry record therefore leaves the central clinical-effect question unanswered. It identifies the population context, intervention approaches, outcome measures, and some baseline data, but does not provide a posted estimate of the mobile program’s effect after treatment. Conclusions about effectiveness, quality of life, or care quality are not supported by the available outcome results.

12. Why This Trial Matters Statistically

This study is statistically informative in part because it illustrates the importance of matching an outcome’s timing to the question being asked. Caregiver burden is named as the primary measure, but the reported value is explicitly from baseline. A baseline score can describe the participants’ starting state; it cannot serve as evidence that an intervention changed that state. Recognizing this distinction prevents descriptive results from being mistaken for treatment effects.

The record also distinguishes a randomized design from a reported randomized comparison. Randomization is relevant to causal inference, but a design label alone does not provide the effect estimate, its uncertainty, or the analysis details. The posted baseline social-support comparison is not a post-intervention estimate. The trial’s completed status likewise does not supply missing outcome results.

The planning illustrations show why sample-size figures need context. They use an observed effect and stated assumptions, and are identified as planning illustrations rather than the trial’s own design. Such calculations are not observed power and do not substitute for a protocol-based sample-size justification. The registry record does not report that justification.

Finally, outcome availability and analysis transparency matter. The record lists post-intervention measures but does not post their results or analyses, and it does not describe multiplicity or missing-data methods. This limits the ability to assess precision, selective availability, and robustness. The statistical lesson is not a conclusion about the intervention; it is that the strength of a clinical claim depends on whether the reported estimand, measurement timing, and analysis match the question.

13. 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.

A central limitation is that the named primary endpoint is reported at baseline rather than after intervention. The available CBI results therefore cannot quantify a treatment effect. Although secondary outcomes include post-intervention measures, their values and analyses are not reported in the registry record. This prevents assessment of change in caregiver burden, social support, or dementia-care knowledge.

The posted group counts for baseline caregiver burden are 27 and 28, while total enrollment is 60. The registry does not explain the relationship between enrollment and the posted outcome counts. The primary outcome description refers to withdrawal because of the care recipient’s death, but does not report the number affected or how such withdrawals were handled. This leaves the completeness and analysis population uncertain.

Other design and analysis details are also absent from the registry record, including the randomization procedure, allocation concealment, identity of the masked party, prespecified treatment contrast, statistical model, missing-data strategy, and sample-size justification. The single-masked designation does not clarify who was masked. Multiplicity procedures, interim analyses, and sensitivity analyses are not reported.

The mobile-program description identifies an app medium and broad intervention schedule, but detailed implementation and adherence results are not reported in the registry record. The record lists deaths by group but does not clarify timing or attribution, and it does not provide an analysis of those counts. These limitations restrict interpretation of both effectiveness and safety. They do not demonstrate that the intervention had no effect; they indicate that the posted results do not permit that effect to be estimated.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: A Study of Mobile Medical Supportive Care Program for Family Caregivers With Dementia Combined With Diabetes — NCT06785857.
• Registry record last updated 2025-12-16; status last verified 2025-11.
• Results first posted 2025-12-16.
• 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.

17. Record Summary

NCT06785857 is a completed randomized, single-masked, parallel-group study with enrollment of 60. It compared a mobile supportive care program added to monthly home visits with offline supportive care. The record describes the use of “Xiamen iHealth” for online support and consultation in the mobile group.

The named primary outcome is caregiver burden measured with the CBI at baseline. The registry posts baseline medians and inter-quartile ranges for the groups, but no post-intervention primary result or treatment-effect analysis. A baseline social-support comparison is also posted; post-intervention secondary results and analyses are not reported in the registry record.

The record does not report the statistical analysis plan, missing-data handling, analysis population, multiplicity approach, or sample-size justification. The planning illustrations are based on an observed effect and are not the trial’s own design or observed power. Accordingly, the posted results describe some baseline measurements but do not establish the intervention’s effect.