Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers (NCT05202223), a na na study. The primary outcome is Change in Caregiver Mastery.

2. Clinical Question

The study focuses on whether a telehealth program can support caregivers in adapting the home environment for a person with ADRD. The rationale described in the registry is that the fit between a person and their surroundings—including access to features of the home and environmental conditions—may be relevant to behavior and support needs. The intervention is intended to help caregivers assess those surroundings and make modifications; the primary outcome, however, is caregiver mastery rather than a direct measure of the home environment or the person with ADRD.

The record also describes focus groups for the first 10 caregiver participants to enroll. Those participants were to be invited to discuss their experiences as dementia caregivers in rural areas and their perceptions of the intervention’s acceptability and usefulness. This qualitative component complements the mastery measure but is not a randomized comparison. Its findings are not reported in the registry record.

3. Trial Design

This is a completed, single-group pilot study, with allocation listed as NA and masking listed as NONE. The registry record lists enrollment as 80. These design details do not establish how many participants contributed data to each assessment or how many completed every visit. The record does not describe a concurrent control group, random assignment, or a masked comparison. As a result, changes measured over time would be within-group observations rather than a treatment-versus-control contrast.

The intervention is Harmony at HOME (H@H), described as a 6-week telehealth intervention delivered by an occupational therapist during weekly visits. Its stated aim is to train caregivers of people with moderate to severe ADRD to assess and modify the home environment. The study start is listed as 2022-01-15, primary completion as 2022-11-01, and status as COMPLETED.

The primary outcome is change in caregiver mastery. The assessment schedule is baseline, visit 2 (week 6), and visit 3 (week 10). The registry describes the outcome as a mean on the Pearlin Mastery Scale, with standard deviation as the dispersion measure. The scale description identifies four items and a score range of 4 to 16; higher scores indicate greater mastery.

The registry record lists five outcome measures, but does not provide numerical primary-outcome summaries or a statistical analysis for them in the information described. It reports zero analyses. The protocol’s planned statistical methods, sample-size justification, interim analyses, and rules for selecting an analysis population are not reported in the registry record. A planning illustration based on an observed effect is not evidence that the single-group pilot was designed as a two-arm trial or that its sample-size rationale used that illustration.

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

Analysis population for the primary outcome, as defined in the registry: Only caregiver data are reported for this outcome. 1 participant was unable to be contacted for visit 3 data collection

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: 39 dyads completed baseline data collection (39 caregivers and 39 persons with cognitive impairment)

6. Primary Endpoint

The registry lists the primary outcome as Change in Caregiver Mastery, measured over baseline, visit 2 (week 6), visit 3 (week 10).

The primary endpoint is caregiver mastery, measured with the Pearlin Mastery Scale. The registry describes it as a four-item scale assessing the extent to which a participant views life as being under personal control rather than fatalistically ruled. Scores range from 4 to 16, with higher scores indicating greater mastery. The outcome is reported as a mean with standard deviation, consistent with treating the scale score as a continuous measure.

Mastery is relevant to the study’s focus on caregivers because it captures a caregiver-reported view of personal control. It is not a direct measure of whether the home environment was modified, whether those modifications were sustained, or whether behavioral and psychological symptoms changed. The registry’s stated intervention goal is to train caregivers to assess and adapt the home environment; the primary endpoint therefore captures one aspect of caregiver experience rather than every intended or possible consequence of the program.

Assessments are scheduled at baseline, visit 2 (week 6), and visit 3 (week 10). Repeated measurement can describe how scores vary over the study period, but interpreting a change as caused by the intervention requires care in a single-group design. Numerical means, standard deviations, changes, and uncertainty estimates are not reported in the registry record. The direction, magnitude, and precision of any change in mastery therefore cannot be established from the recorded outcome information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary outcome summarize?

The registry identifies the primary outcome as a continuous measure summarized by a mean, with standard deviation used to describe dispersion. In general, a mean gives a central summary of the scores in a group, while a standard deviation describes how spread out individual scores are around that mean. These summaries answer different questions: the mean describes the group’s average score, whereas the standard deviation describes variation among participants. Neither alone describes how uncertain the estimated mean is.

The Pearlin Mastery Scale is described as a four-item measure, with scores ranging from 4 to 16 and higher scores indicating greater mastery. The record specifies assessment at baseline, visit 2 (week 6), and visit 3 (week 10). Reporting the same measure at multiple time points can describe the course of scores, but an analysis must account for the fact that assessments from the same caregiver are related rather than independent.

How should change over time be understood?

In general, a within-person change compares an individual’s later score with that person’s earlier score. A group summary of such changes describes how the enrolled participants changed on average. This is not the same as comparing intervention participants with a separate group receiving another condition. In a single-group study, observed change over time cannot by itself separate the intervention’s contribution from other explanations for change.

The registry record does not report the statistical model, test, or estimation procedure used for the primary outcome. It also does not report a numerical estimate of change or an uncertainty interval. Consequently, no particular repeated-measures method, adjustment strategy, or inferential conclusion can be attributed to the trial from the registry information.

What would an uncertainty interval convey?

General statistical context: a confidence interval is a range of values compatible with the observed data under the assumptions of the method used. A narrower interval indicates greater precision for the estimated quantity, while a wider interval indicates less precision. It is important to distinguish an interval around a mean from an interval around a change; each describes uncertainty in a different estimate. No confidence interval for caregiver mastery is reported in the registry record, so the precision of the primary outcome cannot be evaluated from the available result information.

A p-value, when reported, addresses how compatible the data are with a specified statistical model or null hypothesis. It does not measure the size or practical importance of a change, and it does not remove the limitations of an uncontrolled design. The registry record does not report a primary-outcome p-value or analysis, so statistical significance cannot be assessed.

What does the planning illustration represent?

The record describes a sample-size planning illustration computed from an observed effect. Its stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. For non-time-to-event outcomes, such an illustration is expressed as participants per arm for 80% or 90% power. These are planning concepts, not observed trial outcomes or evidence of the study’s original design.

In general, a power calculation describes the sample size associated with a chosen design, target effect, and statistical assumptions. It does not show that a study had that power after it was completed, and a planning illustration based on an observed effect is not the trial’s protocol unless the record says so. Here, the study is single-group and the registry does not report a randomized two-arm design or its own sample-size justification. No numerical planning results are stated in the registry record, so none can be interpreted as the enrolled or analyzed sample size.

Do distributional features affect the analysis?

General statistical context: methods for continuous outcomes often rely on assumptions about the distribution of scores or model residuals. If observations are strongly skewed, have influential extreme values, or show a pattern of variation not captured by the model, standard errors and intervals may be affected. Over-dispersion is especially a concern for count data when observed variability exceeds what a simple count model expects; it is not a direct substitute for assessing the distribution of a continuous scale score. The registry record does not report diagnostic checks, model assumptions, or any alternative analysis for the mastery scale.

Because the numerical results and analysis details are absent, the most appropriate statistical reading is descriptive: the record states what was measured, when it was measured, and the intended type of summary. It does not provide enough information to reproduce or evaluate an inferential analysis of change.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists five outcome measures, but does not report the statistical analysis for the primary outcome or the other measures. It reports zero analyses. The planned statistical analysis, including whether any adjustment was intended for examining multiple outcomes or time points, is not reported in the registry record. Without that information, it is not possible to determine whether the study used a prespecified hierarchy, selected a single time point for inference, or adjusted statistical tests for multiplicity.

In general, examining several outcomes or several time points can increase the chance of finding an apparently notable result by chance if each is tested separately. Multiplicity procedures can address that issue, but their choice depends on the analysis plan and the role of each outcome. No such procedure should be attributed to this study without registry documentation.

For missing data, the record notes that one participant could not be contacted for visit 3 data collection. It does not give the number of completed assessments at each time point, explain whether there were other missing values, or describe how missing observations were handled. The analysis population—such as whether summaries used all enrolled participants or only participants with observed scores—is not reported in the registry record. Nor are assumptions about missingness or any imputation method described.

These gaps matter because the number and pattern of available observations can influence group summaries and estimates of change. The record’s enrollment figure of 80 does not establish the denominator for every outcome or visit. Without visit-specific denominators and the analysis rules, completeness and potential selection effects cannot be assessed.

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 Harmony at HOME group as 0 among 40 participants at risk. It lists other adverse events as affecting 14 among 40 participants at risk, and deaths as 0. No serious adverse-event terms are listed in the record. These counts describe what was recorded for the group; they do not provide a comparison with an untreated or alternative-treatment group.

In general, an adverse-event count is not by itself evidence that an event was caused by an intervention. Attribution requires information about event definitions, timing, severity, and assessment procedures. The registry record does not provide further detail about the other adverse events or list their terms, so their nature and clinical context cannot be characterized from these figures.

The at-risk counts in the safety record should also be kept distinct from the registry’s overall enrollment figure. The safety counts describe the denominator listed for these events, not necessarily the number contributing data to the caregiver mastery outcome at each time point. The record does not provide additional safety follow-up details or explain how adverse events were collected. Accordingly, the figures support a narrow description of the event counts recorded, not a comparative safety conclusion.

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

The study record establishes that Harmony at HOME was evaluated as a single-group telehealth pilot for caregivers of people with moderate to severe ADRD. The intervention was delivered by an occupational therapist in weekly visits over 6 weeks, and caregiver mastery was identified as the primary outcome at baseline, visit 2 (week 6), and visit 3 (week 10). The record also describes planned focus groups for the first 10 caregiver participants to enroll.

Those details describe the program and its measurement framework, but the registry record does not report numerical primary-outcome results. It therefore does not show whether average mastery scores increased, decreased, or remained similar, nor does it show how precise an estimated change might be. There is also no reported controlled contrast that would distinguish changes associated with the program from changes that might occur over time for other reasons.

The outcome has a specific meaning: it captures caregiver-reported mastery, with higher scale scores indicating greater mastery. It does not directly establish whether the home was modified, whether changes improved person-environment fit, or whether behavioral and psychological symptoms changed. Those aims and questions should not be conflated with the scale’s measured construct.

The registry’s safety counts are also descriptive. They list no serious adverse events or deaths in the recorded group and list other adverse events affecting 14 among 40 participants at risk. Without event descriptions, a comparison group, and further collection details, these counts cannot establish comparative safety or event attribution.

Overall, the record supports understanding the pilot’s purpose, design, outcome definition, and safety counts. It does not support a conclusion about the magnitude or causal effect of the program on caregiver mastery. The qualitative focus-group findings and the statistical analysis details are not reported in the registry record.

13. Why This Trial Matters Statistically

This study is statistically useful to read as a pilot with repeated measurements but no control group. That design can describe the setting, intervention, assessment schedule, and the feasibility of collecting caregiver-reported outcomes. It can also provide a basis for considering what a later evaluation might measure. It does not provide the same evidence as a randomized comparison, because within-group changes are not separated from time-related or other influences.

The choice of caregiver mastery gives the study a defined, participant-focused outcome rather than treating the program’s intended environmental changes as though they were already measured. Keeping the construct clear helps readers avoid interpreting a mastery score as a direct measure of home adaptation or outcomes for the person with ADRD. The registry also describes focus groups intended to gather rural caregiver experiences and feedback, broadening the questions beyond a scale score.

Statistical interpretation depends on results as well as design. Although the outcome definition and time points are stated, the record does not report the primary-outcome summaries or analysis. That absence makes the distinction between a measured endpoint and an observed result especially important: knowing what a study planned to measure does not reveal what the data showed.

The record also illustrates why denominators and missingness need to be considered separately for each outcome and visit. Enrollment is listed as 80, while the safety record uses 40 participants at risk and the outcome description notes one participant could not be contacted for visit 3. These figures refer to different parts of the record and should not be treated as interchangeable evidence of complete follow-up.

For biostatistical interpretation, the central lesson is to separate descriptive pilot evidence, causal evidence, and planning calculations. A planning illustration does not establish the original design or observed precision, and a single-group pattern cannot supply a controlled treatment contrast. The absence of posted outcome estimates leaves the primary statistical question unanswered in the registry record.

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 important limitation for interpreting the primary outcome is that numerical results are not reported in the registry record. There are no posted means, standard deviations, estimates of change, uncertainty intervals, or statistical tests for caregiver mastery. Thus, the primary outcome’s observed direction, magnitude, and precision cannot be evaluated.

The single-group design has no concurrent comparison arm described, and allocation is listed as NA. This limits causal interpretation even if within-group change estimates were available. The registry also lists masking as NONE. The record does not report an analysis plan or explain how outcome collection was standardized, so additional methodological details should not be inferred.

Completeness of outcome data is not fully described. The record notes that one participant could not be contacted for visit 3 data collection, but it does not give visit-specific denominators, detail other missing observations, or describe their handling. Enrollment of 80 should not be assumed to mean that every participant contributed data at every visit.

The primary measure is caregiver-reported mastery, not a direct measure of environmental modifications or outcomes for the person with ADRD. The registry describes focus groups for the first 10 caregiver participants to enroll, but does not report their findings. It also does not report numerical results for the listed outcome measures or the analysis population.

Finally, the registry’s planning illustration is distinct from the pilot’s stated design. The record does not report the trial’s sample-size justification, interim analyses, or full statistical plan. These omissions limit assessment of how the study was designed to answer its research questions and how the posted outcome data—if any—were intended to be analyzed.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers — NCT05202223.
• Registry record last updated 2023-12-29; status last verified 2023-12.
• Results first posted 2023-12-29.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry record describes Harmony at HOME as a completed, single-group pilot of a telehealth program for rural caregivers of people with moderate to severe ADRD. Enrollment is listed as 80. The intervention is described as weekly occupational-therapist visits over 6 weeks, intended to train caregivers to assess and modify the home environment.

The primary outcome is caregiver mastery measured with the Pearlin Mastery Scale at baseline, visit 2 (week 6), and visit 3 (week 10). Higher scores on the scale, described as ranging from 4 to 16, indicate greater mastery. Numerical results and the statistical analysis are not reported in the registry record; the record notes one participant could not be contacted for visit 3 data collection.

Safety figures list 0 serious adverse events among 40 participants at risk, 14 participants with other adverse events among 40 at risk, and 0 deaths. Focus groups were planned for the first 10 caregiver participants to enroll, but their findings are not reported in the registry record.