Activate For Life: mHealth Intervention To Address Pain And Fatigue In Low-income Older Adults Aging In Place: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Activate For Life: mHealth Intervention To Address Pain And Fatigue In Low-income Older Adults Aging In Place (NCT03853148), a randomized na study. The primary outcome is Older Adult Pain Intensity.

2. Clinical Question

3. Trial Design

Activate For Life was a randomized, parallel-group trial with single masking. The registry lists the phase as not applicable and records the study as completed. The study dates run from 2019-02-06 to primary completion on 2022-04-30. Enrollment is listed as 50. The sponsor was the Medical University of South Carolina.

The intervention conditions combine behavioral elements directed at activity, balance, flexibility, mindfulness, or motivation. The registry describes Otago as a program of warm-up, selected strength and balance exercises, and walking. The other older-adult conditions added gentle yogic breathing, with one also adding behavioral activation. A caregiver gentle-yoga and yogic-breathing condition was listed separately. The record does not provide enough detail to determine who was masked or how masking was implemented.

The primary outcome was older-adult pain intensity measured from baseline to 12 weeks. Other listed outcomes cover functional status, balance, sit-to-stand capability, walking ability, depression, self-efficacy, daily steps, and caregiver anxiety. The registry lists 28 outcome measures and 25 posted secondary outcomes. It reports no outcome analyses.

The registry record does not report the intended allocation ratio, allocation concealment procedures, or a sample-size justification. It also does not state the planned statistical contrasts among the intervention conditions. These omissions limit what can be concluded about the design’s original inferential aims, even though randomization and a parallel-group structure are recorded.

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: This questionnaire was given to the older adults only, not the caregivers.

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 Older Adult Pain Intensity, measured over Baseline to 12 weeks.

The primary endpoint is change in mean PROMIS Pain Intensity short-form 3a T-score from baseline to 12 weeks. The questionnaire asks older adults how much they hurt. Its raw summed score can range from 4 to 20 and is converted to a standardized T-score. A T-score of 50 represents the US general-population mean, with a standard deviation of 10 points. Higher scores indicate more pain interference. The registry describes scores below 55 as within normal limits, scores from 55-60 as mild, scores from 61-70 as moderate, and scores above 70 as severe pain intensity.

Using a standardized score allows pain intensity to be interpreted relative to a population reference and provides a defined scale for describing change. A negative change indicates a lower average score at follow-up than at baseline; it is not, by itself, evidence that an intervention caused the change. The endpoint is reported for older adults only, not caregivers. The registry gives arm-level means and standard deviations for change in some conditions, but does not report a comparative analysis, confidence intervals, or the underlying baseline and follow-up means.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Interpreting these results requires distinguishing a descriptive change within an arm from a comparison between randomized arms. The registry posts mean changes and standard deviations for three older-adult conditions. A mean change describes the average movement in scores for participants represented in that condition. A randomized comparison would instead estimate how the change in one condition differs from the change in another, with uncertainty quantified using an appropriate method. No such comparative estimate or analysis is reported in the registry record.

What does the mean change represent?

The endpoint is continuous: each participant’s pain T-score can take values along a numerical scale. Change from baseline to 12 weeks is a derived score for each participant, and the posted arm-level mean summarizes those changes. A negative mean indicates that the average follow-up score was lower than the average baseline score in the analyzed group. This alone does not identify what would have happened without the intervention or separate intervention effects from changes over time, measurement variation, or other influences.

In general, a standard deviation describes how dispersed individual observations are around their group mean. Here it describes variability in participant change scores, not uncertainty in the estimated mean. A confidence interval would express uncertainty about an estimate and would depend on the analysis method and data. Confidence intervals are not reported for this endpoint, so the precision of the arm-level mean estimates cannot be read directly from the posted summaries.

Why does a randomized comparison matter?

Random allocation is intended to support a fair comparison between assigned conditions, but the assignment method alone does not provide the result of that comparison. The primary question concerns relative change between conditions, not simply whether each group’s score moved. A comparative estimate and its uncertainty are needed to assess how compatible the observed data are with a range of possible differences. The registry reports neither the estimate nor an inferential test for the primary endpoint.

In general, confidence intervals are useful because they show both the direction and the range of values reasonably compatible with the data under the analysis assumptions. A narrow interval indicates greater precision than a wide one. Since no interval is reported, readers cannot use the registry results to determine how precisely an arm mean or any difference between arms has been estimated. A p-value alone would not replace an effect estimate and interval; neither is available for the primary comparison in the registry record.

How should the spread in these groups be read?

The posted standard deviations are 0.3, 4.2, and 1.6 for the three arms with outcome summaries. These values describe observed spread, but small arm-level counts—n=8, n=6, and n=4—make the summaries sensitive to the participants represented. The registry does not provide individual observations or additional distributional information. It is therefore not possible to assess from these summaries whether the change scores follow a particular distribution or whether unusual observations strongly influence an arm mean.

In general, unusually variable outcomes can affect the precision and performance of statistical procedures. If data are more variable than a method assumes, uncertainty estimates may be unreliable; if the outcome distribution is strongly asymmetric, methods relying on a normal approximation may also be a poor fit. These are general considerations, not claims that a specific assumption was violated in this trial. The record does not report diagnostic checks or the analysis method used.

What do the planning illustrations mean?

The registry describes planning illustrations based on an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are planning assumptions, not a report of the trial’s original sample-size design. Any such illustration estimates a sample size under selected assumptions; it is not observed power and does not show that a trial with its enrolled participants had a particular probability of detecting an effect. The registry does not report the original sample-size justification, and the posted record does not provide the values needed to interpret specific planning scenarios.

In general, planning calculations depend on the effect chosen as important to detect, the variability of the outcome, the statistical threshold, and the design. If the assumed effect is a fraction of an observed effect, that is a hypothetical planning target rather than an established clinical threshold. A planning illustration should not be used to turn descriptive trial results into evidence of a treatment difference.

What is not available for checking?

The registry records zero analyses. It does not report a statistical model, adjustment variables, handling of repeated measures, a missing-data approach, or a prespecified contrast for the primary endpoint. It also does not report confidence intervals or primary-outcome p-values. Without those details, readers cannot reproduce or evaluate an inferential analysis from the posted summary statistics. The reported numbers support description of the recorded arm-level changes, but not a stronger comparative conclusion.

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("Otago", "Otago + Gentle Yogic Breathing", "Otago + GYYB + Behavioral Activation")
n   <- c(8, 6, 4)
m   <- c(-3.25, -2.8, -0.5)
sp  <- c(0.3, 4.2, 1.6)
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  Otago  8  -3.250  0.300  -3.501  -2.999
CARM  Otago + Gentle Yogic Breathing  6  -2.800  4.200  -7.208  1.608
CARM  Otago + GYYB + Behavioral Activation  4  -0.500  1.600  -3.046  2.046

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 28 outcome measures and 25 posted secondary outcomes, in addition to the primary pain-intensity outcome. Considering multiple outcomes can raise a multiplicity issue: when many hypotheses are tested, the chance of at least one apparently notable result can increase. In general, trial analysis plans may address this by prioritizing outcomes, adjusting thresholds, or using a prespecified testing sequence. The registry record does not report whether any multiplicity strategy was planned or applied. It also reports no analyses, so there are no posted inferential results from which to assess multiplicity handling.

Missing-data methods are likewise not reported in the registry record. For the primary outcome, arm-level counts are shown for three older-adult conditions, while the caregiver condition has n=0 and no estimate. The registry does not explain why those outcome counts differ from the enrollment figure or describe the availability of baseline and follow-up scores. It does not state whether missing measurements were excluded, imputed, or handled through a model.

The analysis population is not defined. The registry does not say whether results are based on all randomized participants, participants who completed the intervention, participants with observed endpoint data, or another group. Those distinctions matter because analyses based on different populations can answer different questions. No conclusions about attrition, adherence, or reasons for missing outcomes should be inferred from the posted counts alone.

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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: fluid buildup around heart (10.0%), hospitalization (10.0%), pneumonia (10.0%).

The registry reports serious adverse events for groups using risk denominators of 10 in each of the first three conditions and 20 in the caregiver condition. One serious event is reported in each of the first three groups and none in the caregiver group. Other adverse events are reported as zero in all four groups. These safety denominators differ from the primary-outcome counts; the registry record does not explain the difference or how the groups were defined for safety reporting.

The listed serious-event terms are fluid buildup around heart, hospitalization, and pneumonia, each shown as 10.0%. The record does not provide enough detail to establish whether these terms refer to separate participants, overlapping events, or how they map to individual groups. One death is reported in the Otago plus GYYB plus Behavioral Activation group; zero deaths are reported in the other groups. The record does not state whether the death was related to an intervention.

These counts are descriptive safety reports, not comparative estimates of risk. The registry record does not report a statistical comparison, causal assessment, or further event-level context. Small reported denominators also mean that the counts alone provide limited information about how safety findings might generalize beyond the participants represented.

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

The posted primary-outcome results show negative mean changes in pain T-score for each of the three older-adult arms with a reported estimate. Since higher T-scores indicate more pain interference, these summaries describe lower average scores at follow-up than at baseline within those arms. The registry does not report a change estimate for the caregiver condition because its primary-outcome count is n=0.

These descriptive findings do not show whether one intervention condition produced greater change than another. They do not establish that an intervention caused the observed within-arm changes, and they do not establish statistical significance. The registry provides no comparative effect estimate, confidence interval, or primary-outcome analysis. The standard deviations describe variability among observed changes, not the precision of a treatment comparison.

The endpoint is a patient-reported measure of pain intensity, expressed as a standardized T-score. It is one part of a broader study that also lists measures of physical function, activity, mental health, and caregiver anxiety. The posted primary-outcome summaries do not establish results for those other measures. Nor do the pain summaries by themselves establish whether participants’ functioning or ability to age in place changed.

The reported safety counts are also descriptive. They record serious adverse events and deaths but do not establish whether an event was caused by an intervention or whether event rates differed between conditions. The registry does not provide a comparative safety analysis.

In short, the record supports a cautious description of selected arm-level pain changes and safety counts. It does not support a conclusion about comparative benefit, a causal effect, or the precision of differences between conditions. A reader seeking those conclusions would need analyses and supporting details not reported in the registry record.

14. Why This Trial Matters Statistically

This trial illustrates an important distinction in clinical statistics: a randomized design and a set of arm-level outcome summaries are not the same as a reported randomized comparison. The registry identifies several intervention conditions and posts mean changes for some of them, but it does not report the analysis needed to estimate differences between conditions. Without a comparative estimate and uncertainty interval, descriptive movement in scores cannot answer the central comparative question.

It also highlights why denominators and analysis populations matter. The registry lists enrollment of 50, but primary-outcome counts vary across the posted arms and the caregiver arm has no older-adult pain estimate. Safety counts use different at-risk denominators. These registry entries are not inherently contradictory, but the record does not explain them. Clear definitions of who contributed to each endpoint and at what time are necessary for readers to interpret results.

The endpoint itself is standardized, but precision still depends on the number and variability of observed changes. The posted arm-level counts are small, and the standard deviations differ. A standardized scale does not remove uncertainty or substitute for confidence intervals. Statistical interpretation must account for both the scale and the amount of information available.

Finally, the trial lists many outcomes, making transparent reporting of a prespecified analysis and multiplicity approach important. The registry record does not report these details or any analyses. This makes the record useful for describing the registered study and its posted summaries, while limiting what can be concluded about comparative efficacy or safety.

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 most important limitation for interpreting the primary outcome is the absence of a reported comparative analysis. The registry posts arm-level changes and standard deviations but no between-condition estimate, confidence interval, or test. It also reports zero analyses. As a result, the precision and statistical evidence for differences between conditions cannot be assessed from the registry record.

Outcome counts vary across the listed conditions, including no older-adult pain result for the caregiver arm. The registry does not explain these counts or specify the analysis population, baseline and follow-up data availability, or missing-data method. The difference between the enrollment figure and the endpoint counts should not be attributed to any particular cause based on this record alone.

The registry does not report the statistical model, planned contrasts, adjustment variables, handling of repeated measurements, or multiplicity strategy. It also does not provide a sample-size justification. These omissions limit assessment of whether the posted endpoint summaries follow the original analysis plan or how multiple outcomes were handled.

The primary endpoint is a self-reported pain measure. The study description also mentions objective activity data, physical measures, and biomarkers, but those measures do not add to the interpretation of the posted pain changes unless their results are reported. No such results should be inferred from the study aims. Finally, safety denominators differ from endpoint counts, and the event-level details and causal assessments are not reported. These limitations make the posted record primarily descriptive.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Activate For Life: mHealth Intervention To Address Pain And Fatigue In Low-income Older Adults Aging In Place — NCT03853148.
• Registry record last updated 2022-07-29; status last verified 2022-07.
• Results first posted 2022-07-29.
• 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.

19. Record Summary

The registry record describes Activate For Life, a completed randomized, single-masked, parallel-group study sponsored by the Medical University of South Carolina. Enrollment is listed as 50, and the recorded study dates are 2019-02-06 to 2022-04-30. The intervention conditions combined Otago exercise with gentle yogic breathing and, in one arm, behavioral activation; a caregiver gentle-yoga and yogic-breathing condition was also listed.

The primary endpoint was change in older-adult PROMIS Pain Intensity T-score from baseline to 12 weeks. Mean changes and standard deviations are posted for three older-adult arms, but no comparative primary-outcome analysis is reported. The caregiver arm has no primary pain estimate. The registry lists 28 outcome measures, 25 posted secondary outcomes, and zero analyses. Safety results report serious events, other adverse events, and deaths by group, without a comparative safety analysis. Missing-data methods, the analysis population, multiplicity handling, and the original sample-size rationale are not reported in the registry record.