Reporting Patient Generated Health Data and Patient Reported Outcomes With Health Information Technology: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Reporting Patient Generated Health Data and Patient Reported Outcomes With Health Information Technology (NCT03386773), a randomized na study. The primary outcome is Patient Engagement (Patient Activation Measure).

2. Clinical Question

The study concerns whether a program using health information technology can engage patients in sharing patient-generated health data and patient-reported outcomes. Its stated focus is feasibility in diverse, low-income disadvantaged populations. Obesity is the listed condition.

The broader stated aim is to collect patient-generated health data and patient-reported outcomes using patient-centered, commercial off-the-shelf health information technology, then map and report those data in ways intended to support their use in care delivery and integration with health information systems. The registry record does not report whether those data were successfully integrated or used in clinical care.

3. Trial Design

This was a randomized, parallel-group behavioral study sponsored by Denver Health and Hospital Authority. The registry record lists an enrollment of 300 and describes the study as completed. The listed start date is 2018-11-02, and the primary completion date is 2019-07-19. The phase is recorded as NA.

The two groups shared an important feature: both were assigned a 16-week program with regular health promotion messaging about food, nutrition, diet, exercise, and physical activity. The intervention group was additionally asked to track patient-generated health data elements related to weight. The control description specifies collection of patient-reported outcome measures before and after the intervention. The record does not report whether control participants also tracked data beyond what is stated in the group description.

Masking is listed as none. That means the study is recorded as unmasked; the registry record does not report further details about who knew group assignments or whether outcome collection or analysis involved any masking. Allocation is listed as randomized, but the randomization sequence method, allocation concealment, and procedures for assigning participants are not reported in the registry record.

The study’s stated purpose centers on feasibility and on making patient-generated data and reported outcomes actionable through mapping and reporting. The registry record does not report the specific feasibility criteria, targets, or decision rules. It also does not report a protocol rationale for the enrollment, a statistical analysis plan, or details of participant follow-up beyond the stated baseline and post-intervention measurement times.

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: The number of participants analyzed reflects the number for which complete data were available.

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 Patient Engagement (Patient Activation Measure), measured over Baseline, Post-Intervention.

The primary endpoint is patient engagement measured with the Patient Activation Measure (PAM)-13. The instrument has 13 items, each rated on a four-point per-item scale. Responses are converted to a total PAM score and then transformed using calibration tables into a scale score ranging from 0 to 100. Higher scores reflect better scores and indicate increased engagement. The registry record says the scale score is reported.

Patient activation is relevant to the study’s stated interest in patients taking an active role in managing their health. The measure offers a standardized way to describe engagement rather than relying only on whether a participant used a particular technology or sent a particular data item. The registry record lists baseline and post-intervention as the measurement times.

The endpoint is described as a mean with standard deviation as its dispersion measure. Those summaries can describe the average scale score and variation among participants, but they do not by themselves show the size or precision of a between-group effect. The registry record does not report the endpoint values, group comparison, confidence interval, or test result. It also does not report how a change in this scale should be interpreted in terms of a clinically meaningful difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General statistical context: a trial design specifies how participants are assigned, what groups receive, which outcomes are measured, and how comparisons are intended to be made. The registry record identifies randomized allocation and a parallel-group structure. In a parallel design, participants are assigned to a group and the groups are followed alongside one another. The record does not report the method used to generate or conceal assignments, so the practical details of randomization cannot be assessed from the registration information.

What does a mean and standard deviation describe?

The primary outcome is a continuous scale score, summarized in the registry as a mean with standard deviation. A mean describes the average score among participants included in a group’s analysis. The standard deviation describes how spread out individual scores are around that average. They answer different questions: the mean describes the group’s central level, while the standard deviation describes variability among participants. A standard deviation is not the uncertainty of the mean and is not a confidence interval for a treatment effect.

For a comparison of randomized groups, a mean difference can describe how far apart their average scores are. A confidence interval around that estimate can communicate its precision. Such a comparison could be based on post-intervention scores, changes from baseline, or an adjusted model, but those approaches are not interchangeable in every setting. The registry record does not report which method was used or provide the estimates needed to interpret any such comparison.

Why do measurement times matter?

The PAM score is listed at baseline and post-intervention. Repeated measurement makes it possible to describe scores at each time and to assess change, but the analysis must define the comparison being estimated. A baseline-to-post change within the intervention group alone does not isolate the effect of group assignment; changes in the control group also matter when assessing a comparative effect. General statistical context: an analysis that accounts for baseline measurements can sometimes improve precision, depending on the design and method. The registry record does not report whether baseline scores were used as covariates, whether change scores were calculated, or what model was fitted.

The primary outcome is flagged as having several categories or time points and is not reduced to one comparison. This matters because multiple possible contrasts can answer different questions. A score at post-intervention, a change from baseline, and comparisons at other time points would not represent the same estimand. The registry record does not report which contrast was designated for statistical testing or how multiple comparisons were handled.

What can be said about significance and precision?

General statistical context: statistical significance is a property of a test result under a particular model and null hypothesis, not a direct measure of effect size or importance. Confidence intervals are useful alongside tests because they show which effect sizes remain compatible with the data and analysis assumptions. A precise estimate has a relatively narrow interval; an imprecise estimate has a wider interval. The registry record reports no primary outcome estimate, confidence interval, or p-value, so significance and precision cannot be evaluated.

The record notes that planning illustrations use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation, with the target effect expressed as a stated fraction of the observed effect. These are described as planning illustrations based on the observed effect, not as the trial’s own design assumptions. No planning-illustration counts are included in the registry information, and the record does not report the original sample-size justification or its assumptions. Such illustrations are not observed power and do not replace an analysis of the trial results.

Why can variability affect an analysis?

General statistical context: when outcome variation is larger, group averages can be estimated less precisely for a given amount of information. If a continuous outcome has a distribution with unusually heavy tails or values concentrated in a way that departs from model assumptions, the usual analysis may not describe uncertainty adequately. Over-dispersion is especially relevant to count outcomes when observed variability exceeds what a chosen count model expects. It is not a reported feature of the PAM score in this registry record, and there is no basis to claim that over-dispersion affected this study.

The primary measure is bounded by its scale, and its score is transformed using the instrument’s calibration tables. General statistical context: bounded scores may not behave like unbounded measurements in every sample, and distributional checks can help assess whether a selected model is suitable. The registry record does not report score distributions, diagnostic checks, transformations beyond the instrument scoring, or any sensitivity analyses.

What does randomization not resolve by itself?

Randomization addresses allocation, but interpretation also depends on follow-up, missing outcome data, adherence, and the analysis population. General statistical context: excluding participants with incomplete outcomes can change the composition of the analyzed groups if completeness is related to participant characteristics or outcomes. The registry record says the number analyzed reflects participants with complete data, but it does not report the number with complete data, reasons for missingness, or any method for handling missing values.

The registry record reports no analyses in its analysis count, and the primary outcome values and comparative estimates are not posted. It also does not report a prespecified statistical analysis plan, model assumptions, covariate choices, interim analyses, or sensitivity analyses. These omissions limit assessment of how the results would have been generated and whether the analysis addressed the planned randomized comparison.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when an analysis considers multiple outcomes, time points, groups, or comparisons. If many hypotheses are tested, the chance of at least one apparently notable result can increase unless the analysis plan accounts for the testing strategy. General statistical context: adjustment procedures or a prespecified hierarchy can help define how multiple tests should be interpreted, but no single approach is appropriate without knowing the intended questions and analysis plan.

The registry record lists baseline and post-intervention time points for the primary PAM outcome and flags that the primary outcome has several categories or time points and is not reduced to a single comparison. It also lists secondary outcomes of weight loss, Healthy Days HRQOL-4, Healthy Days Symptoms, and the number of patients who responded to text messages. The record does not report which comparisons were primary for inference, how multiplicity was managed, or whether a hierarchy or adjustment procedure was used. Those details are not reported in the registry record.

The primary outcome description says the number analyzed reflects participants with complete data available. The number analyzed and the amount or pattern of missing outcome data are not reported in the registry record. Reasons for missing data, imputation methods, sensitivity analyses, and the treatment of participants who did not complete the intervention are also not reported in the registry record.

The record therefore does not establish whether the analysis population included all randomized participants, only participants with complete measurements, or another defined population. A complete-case description indicates how analyzed counts are characterized, but it does not by itself show whether missingness could bias a comparison. No intention-to-treat analysis is reported in the registry record.

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.

The registry record reports zero serious adverse events and zero other adverse events in the intervention group, with 150 participants at risk for each category. It reports the same figures for the control group: zero serious adverse events and zero other adverse events, with 150 participants at risk. Deaths are reported as zero in each group, and no serious adverse event terms are listed.

These figures describe what the registry record reports; they are not a substitute for details about how adverse events were collected, defined, monitored, or attributed. The registry record does not report such procedures, nor does it provide event narratives or follow-up duration for safety. A zero count in a posted record means no events are reported in that category for the listed group. It does not, by itself, establish that all possible harms were actively assessed or that no unrecorded events occurred.

The counts should be read as safety reporting rather than as evidence about the primary engagement outcome. The registry record does not report a statistical comparison of adverse-event rates, and the reported counts do not supply an estimate of the effect on patient engagement.

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

The registry record describes a randomized study intended to assess feasibility of collecting and reporting patient-generated health data and patient-reported outcomes through health information technology in diverse, low-income disadvantaged populations. It also specifies a patient engagement measure and the program activities assigned to the intervention and control groups. These details clarify the study’s question and planned outcome, but they are not outcome findings.

The primary score is designed so that higher scores indicate better scores and increased engagement. However, the record does not post group scores at baseline or post-intervention, a change estimate, a between-group comparison, or an uncertainty interval. It is therefore not possible to determine from the posted results whether engagement changed, how large any change was, or how precisely it was estimated.

General statistical context: randomization can support a fair comparison of assigned groups when allocation and analysis are conducted appropriately. It does not automatically resolve incomplete follow-up, differences in adherence, measurement limitations, or the effects of selecting only participants with complete data. The record’s complete-data description and absence of reported analysis details leave those issues unresolved.

The study summary describes intended data mapping to support use in interoperable electronic health records, clinical information systems, and larger data infrastructures. The registry record does not report evidence that integration occurred, that collected information changed care processes, or that the technology was acceptable or usable to participants. The stated study purpose should not be mistaken for a reported outcome.

Likewise, the listed secondary outcomes are not accompanied by posted results in the registry information. No conclusions about weight loss, healthy days, symptoms, or text-message responses can be drawn from their names alone. The reported adverse-event counts are safety entries and do not answer the study’s primary engagement question.

Overall, the record supports a description of the study design, measurement instrument, and intended comparison. It does not support a conclusion about the size, direction, statistical significance, or practical importance of an effect. The absent outcome estimates and analysis details are central limits on interpretation.

13. Why This Trial Matters Statistically

This study addresses a statistical and measurement problem that arises when health data come directly from patients and digital tools rather than only from clinical encounters. The study summary describes an aim to collect patient-generated health data and patient-reported outcomes and map them for potential use across health information systems. Evaluating such work involves more than asking whether an intervention changes a clinical score: completeness, usability, and the ability to interpret and integrate data are also relevant.

The randomized parallel-group design offers a framework for comparing two program arrangements. Both groups received health promotion messaging, while the intervention description also includes tracking patient-generated health data related to weight. That structure makes it important to identify the exact contrast of interest: the posted record does not report whether the intended estimate concerns the added tracking activity, engagement over time, or a broader feasibility question.

The PAM-13 measure connects the technology-focused aim with a patient-centered outcome. Its transformed scale gives a standardized way to represent patient activation, while the baseline and post-intervention times permit assessment of change. Statistically, the interpretation still depends on the chosen comparison, the distribution of scores, missing data, and the precision of the estimate. Those results and methods are not reported in the registry record.

The record also illustrates why feasibility aims need explicit operational outcomes. A study can state an intention to make data actionable, but assessing that aim requires results about collection, mapping, reporting, or integration. Those results are not reported in the registry record. With results absent, the study’s statistical importance lies in the question and design it describes, not in evidence of a measured effect.

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.

A central limitation for interpretation is that the registry record does not report primary or secondary outcome results. It gives no PAM group summaries, comparative estimate, confidence interval, p-value, or numbers analyzed. The primary outcome population is described as participants with complete data, but the number of participants with complete data is not reported in the registry record.

The record also does not report a detailed statistical analysis plan, the randomization procedure, allocation concealment, methods for addressing missing data, or any multiplicity strategy. The primary outcome is listed at baseline and post-intervention and is flagged as not reduced to a single comparison. This leaves the precise intended estimand and testing approach unclear.

The intervention and control descriptions both include the same stated health promotion topics, while the intervention description adds tracking of patient-generated health data related to weight. The registry record does not report adherence, actual data-tracking activity, message delivery or receipt, or further detail about the control group’s data-collection activities. Those omissions limit assessment of what participants experienced and how distinct the groups were in practice.

The study summary emphasizes feasibility and data mapping for potential use in interoperable systems, but specific feasibility criteria and results for mapping or integration are not reported in the registry record. The record also does not provide detailed eligibility criteria, participant characteristics, or follow-up information beyond the listed endpoint time points. These gaps constrain assessment of the study population and the scope of any potential generalization.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Reporting Patient Generated Health Data and Patient Reported Outcomes With Health Information Technology — NCT03386773.
• Registry record last updated 2022-09-26; status last verified 2022-09.
• Results first posted 2022-09-26.
• 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.

18. Record Summary

NCT03386773 is a completed randomized, parallel-group behavioral study sponsored by Denver Health and Hospital Authority. It lists an enrollment of 300, a start date of 2018-11-02, and a primary completion date of 2019-07-19. The listed condition is obesity, and the stated focus is feasibility of collecting and reporting patient-generated health data and patient-reported outcomes through health information technology.

Both groups were assigned a 16-week program with regular health promotion messaging about food, nutrition, diet, exercise, and physical activity. The intervention group was also asked to track patient-generated health data elements related to weight. The primary outcome is PAM-13 patient engagement at baseline and post-intervention, reported as a scale score intended to range from 0 to 100, with higher scores indicating increased engagement.

Primary and secondary outcome results, comparative estimates, and detailed statistical methods are not reported in the registry record. The record reports zero serious adverse events, zero other adverse events, and zero deaths in each group.