Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease. (NCT06170866), a na na study. The primary outcome is Acceptability of Intervention Measure (AIM).

2. Clinical Question

The study is primarily framed as a cultural adaptation and feasibility investigation, rather than a controlled test of whether the program changes health outcomes. The intervention was designed around peer partnership and mobile health support. Participants were asked to connect with another person with Parkinson's disease weekly on a virtual platform and to use Fitbit activity monitors and the Fitbit application. The study also included research-grade activity monitoring at the beginning and end, educational content, and online group exercise.

Because all participants were in one group, changes over time could be described, but this design alone cannot distinguish intervention effects from other explanations for any observed change. The registry record does not report outcome estimates or analyses that would answer whether the intervention changed physical activity or other measures. The reported primary question is whether the intervention is acceptable to participants after completing it.

3. Trial Design

This is a completed interventional study with a single-group model and no masking. The registry record lists allocation as NA and does not describe a randomized assignment or a separate comparator group. Enrollment is listed as 10. The sponsor is UConn Health, and Parkinson Disease is the listed condition. The study is titled “Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease.”

The stated purpose is to culturally adapt and determine the feasibility of peer partner training and a peer-supported mobile health physical activity intervention for older Latin/Hispanic people with Parkinson's disease. Participants were asked to complete a set of activities that included wearing an Actigraph GT9X research-grade activity monitor for 10 days at the beginning and end of the study, watching 11 educational videos about Parkinson's disease and exercise, and attending two virtual educational sessions. They were also asked to meet virtually with another person with Parkinson's disease one time a week for 8 weeks, use Fitbit activity monitors and connect through the Fitbit application for 8 weeks, and attend a weekly online exercise class for 8 weeks.

The primary outcome is acceptability after completion of the entire intervention, with a stated timeframe of 11 weeks. Secondary outcomes listed in the record include objective measurement of physical activity, the Behavioral Regulation in Exercise Questionnaire-2, the Parkinson's Disease Questionnaire-39, and the Geriatric Depression Scale-Short Form. The brief description also mentions motivation, depression, apathy and self-efficacy as areas of interest. The record lists 7 outcome measures, but it does not report the full results or analyses for those measures.

The study status is COMPLETED. The registry record lists a start date of 2023-06-01 and a primary completion date of 2024-07-01. A protocol-level statistical analysis plan, sample-size justification and interim 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.

Overall Study

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 Acceptability of Intervention Measure (AIM), measured over After completion of the entire intervention (11 weeks).

The primary endpoint is the Acceptability of Intervention Measure (AIM), assessed after completion of the entire intervention, with a timeframe of 11 weeks. It is described as a standardized measure of acceptability that indicates percent agreement with acceptability of the intervention. Scores range from 20-100%, and higher scores indicate greater agreement that the intervention is acceptable.

Acceptability is useful in a feasibility study because it addresses whether participants view the intervention as acceptable, rather than directly establishing whether the intervention changes physical activity or another health outcome. An intervention can be acceptable without demonstrating a change in behavior, and a behavioral change would not by itself establish acceptability. These are different questions and should be interpreted separately.

The registry record specifies that the endpoint is summarized as a mean with standard deviation. A mean describes the average score in the analyzed group, while a standard deviation describes how much individual scores vary around that average. The record does not report the observed AIM mean, its standard deviation, the number assessed at the endpoint, or an uncertainty interval. Therefore, the posted registry information does not allow readers to judge the observed level of acceptability or the precision of its estimate.

The score's stated range and direction help explain how a reported result would be interpreted, but they do not supply the result itself. The registry record also does not report a threshold for classifying a score as acceptable or a comparison value. The endpoint should therefore be read as a planned measure of participant-reported acceptability, not as evidence of intervention effectiveness.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the single-group design tell us?

In a single-group study, participants receive the intervention without a separate control group. This design can help describe whether a program can be delivered and how participants respond to it. It can also describe measurements collected before and after participation, if those results are reported. However, without a concurrent comparison group, a change over time cannot be attributed uniquely to the intervention. Statistical adjustment cannot fully replace the missing comparison when the record does not include information that would support such an adjustment.

For this study, the registry identifies a single-group model and no masking. It does not report a randomized allocation or control arm. Thus, the central interpretive focus is feasibility and acceptability, as stated in the study purpose, rather than a controlled estimate of treatment effect.

What do the mean and standard deviation describe?

The primary outcome is continuous and is defined as a mean with standard deviation. A mean is the arithmetic average of participant scores. It gives a summary of the group's score level, but it does not show whether every participant had a similar score. The standard deviation describes the spread of individual scores around the mean. A larger spread indicates more variation in scores within the group, while a smaller spread indicates that scores are more clustered. These are general statistical interpretations.

A standard deviation is not the same as a confidence interval. A confidence interval expresses uncertainty about an estimated quantity, such as a group mean, under the assumptions of the analysis. It helps readers assess the range of values compatible with the data and method. The registry record does not report a confidence interval for the primary endpoint, nor does it provide the mean and standard deviation needed to describe the observed AIM results.

Why does the endpoint scale matter?

The AIM is described as indicating percent agreement, with scores from 20-100% and higher values indicating greater agreement with acceptability. A scale's direction matters because it determines which way to interpret larger values. Here, higher scores are described as better for the specific construct of acceptability. That direction should not be generalized to other outcomes: higher values on another measure may have a different interpretation depending on its definition.

The stated scale range does not identify a cut point for acceptable versus unacceptable intervention ratings. No such threshold is reported in the registry record. A mean alone, if it were reported, would also not show the distribution of individual ratings. The standard deviation would provide information about variability, while participant-level data or additional summaries could describe the distribution in more detail.

What can feasibility results establish?

Feasibility concerns whether an intervention and its study procedures can be implemented. In this study, the stated feasibility questions concern peer partner training and the peer-supported mobile health physical activity intervention. Relevant measures might include the ability to deliver activities, participation, completion or acceptability, but the registry record does not specify a complete set of feasibility criteria or thresholds. It does not report feasibility results, so no conclusion about whether the program met a feasibility standard can be drawn from the posted record.

Acceptability and feasibility are related but distinct. Participants may consider a program acceptable even if delivery is difficult, or delivery may be possible even if participants do not rate it favorably. The primary AIM endpoint addresses acceptability; the record's broader purpose includes feasibility. Keeping these questions separate avoids treating one measure as an answer to all aspects of implementation.

Why is a control group important for causal interpretation?

A comparison group helps distinguish changes associated with an intervention from changes that might have occurred without it. In a randomized trial, random assignment can support a more credible comparison by balancing, on average, factors that could affect outcomes. This study is not described as randomized and has no separate control group. Therefore, any before-and-after contrast would be descriptive and would not alone establish what would have happened to participants without the intervention.

The intervention combines peer support, family and group support, mobile health tools, education and group exercise. A single-group evaluation can describe the combined program, but it cannot determine which component accounts for a change. A component-specific conclusion would require suitable comparisons and an analysis designed for that question; neither is reported in the registry record.

How should missing results and analysis details be handled?

The registry record does not report an analysis plan, interim analysis plan, sample-size justification, or outcome-analysis results. It also does not report the number of participants with observed data for each endpoint, reasons for missing measurements, or how missing values were handled. These omissions limit evaluation of the analysis and the extent to which reported outcomes, if later posted, represent everyone enrolled.

The enrollment of 10 is not a substitute for an outcome-specific analysis count. Different measures can have different amounts of missing data, and the number contributing to an estimate may vary by endpoint. The record lists 7 outcome measures but does not give a complete set of corresponding results. No unadjusted recalculation or planning illustration can be interpreted as an observed trial result when the necessary summary statistics are not reported.

Multiplicity refers to the statistical challenge created when several outcomes or hypotheses are examined. If many tests are conducted, the chance of at least one apparently unusual result can increase. Methods such as prespecifying a primary outcome or adjusting inference can address aspects of this issue, but the relevant analysis choices are not reported in the registry record. It is therefore not possible to determine how the study handled multiplicity or whether secondary findings were intended as confirmatory or exploratory.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Social support for physical activity")
n   <- c(10)
m   <- c(93)
sp  <- c(8.56)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Social support for physical activity  10  93.000  8.560  86.877  99.123

11. Multiplicity, Missing Data and Analysis Populations

The registry record names AIM acceptability as the primary outcome and lists secondary outcomes that include objective physical activity measurement, the Behavioral Regulation in Exercise Questionnaire-2, the Parkinson's Disease Questionnaire-39 and the Geriatric Depression Scale-Short Form. The study description also identifies motivation, depression, apathy and self-efficacy as areas of interest. The record lists 7 outcome measures but does not provide all outcome results or a statistical analysis plan.

When a study examines multiple outcomes, multiplicity can affect how evidence is interpreted. Testing many hypotheses can increase the chance that at least one result appears notable by chance. Researchers may address this by specifying which outcome is primary, defining a hierarchy, or using an adjustment approach. The registry record does not report whether any such approach was planned or used. It also does not report whether secondary analyses were intended to be confirmatory or exploratory.

Missing-data methods and analysis populations are also not reported. The record lists enrollment as 10, but does not state how many participants contributed data to the primary endpoint or each secondary outcome. Reasons for missing data, endpoint completion rates and methods for handling missing values are not reported in the registry record. Without those details, readers cannot assess whether the available outcome data may differ systematically from the data that would have been observed for all enrolled participants.

The statistical analysis plan, interim analyses and sample-size justification are not reported in the registry record. These omissions prevent assessment of whether the analyses followed prespecified methods or how the study's size was justified. No inference about the intended analysis population, multiplicity control, or handling of incomplete observations should be assumed.

12. 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 record lists 0 serious adverse events, 0 other adverse events and 0 deaths for the Social support for physical activity group. Each category lists 10 participants at risk. These are descriptive safety counts for the group in this single-group study, not a comparison between intervention and control.

A count of 0 means that no events in that category are recorded in the registry entry. It does not establish that the risk of an event is absent, nor does it show how event rates would compare with another group. The record does not report event narratives, severity definitions, follow-up completeness or additional details about how adverse events were collected and assessed.

Because there is no separate control group, these figures cannot quantify a relative safety difference associated with the program. The registry record also does not report a detailed safety analysis or uncertainty estimates. The listed counts should therefore be read as the posted event record for this study, with the limitations of a small, single-group evaluation.

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

The study is designed to address whether a peer-supported physical activity program can be culturally adapted and whether its delivery and acceptability can be assessed among older Latino and Latina adults with Parkinson's disease. It combines peer connection, family and group support, mobile health tools, educational activities and online exercise. The primary endpoint is a participant-reported measure of acceptability after the intervention.

The registry record does not report the observed primary endpoint result. It therefore does not establish how acceptable participants found the program. It also does not report results for the physical activity and other outcomes described in the record. No conclusion about improvement, lack of improvement, or the size or precision of any change can be drawn from the posted outcome information.

The single-group design also limits causal interpretation. Even if a change from the beginning to the end of the study were reported, that change alone would not show that the intervention caused it. Without a separate comparison group, changes could reflect influences other than the program. The design also cannot identify whether any change was associated with peer support, family or group support, the mobile applications, educational material, exercise classes, or their combination.

The posted safety counts record 0 serious adverse events, 0 other adverse events and 0 deaths among the listed group at risk. These figures describe what is recorded, not a comparative estimate of safety or proof that adverse events cannot occur.

Accordingly, the study record supports a description of the intervention, its feasibility and acceptability aims, and the outcomes selected for evaluation. It does not support a claim that the program works or does not work. Outcome estimates, participant counts for each analysis, missing-data information and analysis methods are not reported in the registry record, so the strength and precision of any outcome evidence cannot be evaluated from the posted information.

14. Why This Trial Matters Statistically

Small feasibility studies can address practical questions that precede a larger evaluation: whether a program can be delivered, whether its components fit participants' needs, and whether participants find it acceptable. These questions are especially relevant when an intervention combines social support, digital tools and group activities. This study explicitly focuses on cultural adaptation and feasibility for older Latino and Latina adults with Parkinson's disease.

The statistical distinction between feasibility and effectiveness is important. The primary measure, AIM, concerns acceptability, while the broader study description names physical activity and other participant outcomes. A favorable result on an acceptability measure would not by itself demonstrate a change in activity or health. Likewise, a change in an outcome would not alone show that the program was acceptable or feasible to deliver. Each question requires appropriate outcome information and interpretation.

The single-group design can provide descriptive information about participants who take part, but it cannot by itself separate program-related change from changes that might occur over time for other reasons. Recognizing this design feature prevents an uncontrolled before-and-after observation from being interpreted as a causal treatment effect.

Reporting the endpoint mean, its variability, the number assessed and uncertainty would help readers judge the observed acceptability result and its precision. Reporting outcome-specific analysis counts, missing-data methods and the analysis plan would further clarify how the results were produced and how much confidence to place in them. These details are not reported in the registry record.

The posted entry thus identifies an important set of implementation questions and a multifaceted intervention, while leaving its outcome evidence unavailable for statistical appraisal. That distinction is central to reading a feasibility study responsibly: a clear research aim is not the same as a reported result, and a result from a single group would still need cautious interpretation.

15. 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 leaves several trial-specific limitations and interpretation gaps. The single-group model has no separate control group, so the study cannot provide a like-for-like comparison. The lack of a reported randomized allocation also means that causal conclusions cannot be based on an assignment process described in the record. The intervention combines multiple elements, making it impossible to isolate the contribution of peer contact, family and group support, mobile health tools, educational material or exercise classes from this design alone.

The registry record does not report the observed AIM mean or standard deviation, despite identifying AIM as the primary endpoint. It also does not report outcome-specific analysis counts, confidence intervals, missing-data methods, or complete results for the listed outcomes. As a result, the level and precision of acceptability and other outcomes cannot be assessed from the posted information.

The enrollment is listed as 10, but detailed eligibility criteria, participant characteristics and reasons for noncompletion are not reported in the registry record. These omissions limit assessment of whom the findings would represent, even if outcome estimates were available. The record does not specify a threshold for judging AIM scores as acceptable or a complete set of feasibility criteria.

The statistical analysis plan, sample-size justification, interim analysis plan, multiplicity approach and analysis populations are not reported in the registry record. The intervention's several activities also make implementation exposure potentially complex, but adherence or participation results are not reported. Finally, the listed adverse-event counts are descriptive and do not supply a controlled safety comparison or detailed event information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Peer Partners to Improve Physical Activity in Older Latino and Latina Adults With Parkinson's Disease. — NCT06170866.
• Registry record last updated 2025-11-26; status last verified 2025-10.
• Results first posted 2025-11-26.
• 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.

19. Record Summary

NCT06170866 is a completed, interventional, single-group study sponsored by UConn Health. It evaluates a culturally adapted peer-supported physical activity program for older Latino and Latina adults with Parkinson's disease. Enrollment is listed as 10. The intervention combines peer, family and group support with activity monitoring, educational activities, virtual peer connection and online exercise.

The primary outcome is the Acceptability of Intervention Measure, assessed after completion of the intervention over a stated timeframe of 11 weeks. The record describes higher scores as indicating greater agreement with acceptability. Secondary outcomes include objective physical activity measurement, exercise regulation, Parkinson's disease quality of life and depression measures.

The registry record does not report the observed primary endpoint result, outcome-specific analysis counts, missing-data methods or a statistical analysis plan. The listed safety figures are 0 serious adverse events, 0 other adverse events and 0 deaths. With no separate control group and no posted outcome estimates, the record describes the study aims and design but does not establish an intervention effect.