Implementing HEARTS in Guatemala: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Implementing HEARTS in Guatemala (NCT06080451), a non-randomized na study. The primary outcome is Score on Feasibility of Intervention Measure (FIM) Questionnaire.

2. Clinical Question

3. Trial Design

This was a completed, non-randomized, single-group pilot registered as NCT06080451. It examined implementation of integrated diabetes and hypertension management based on the HEARTS model in Guatemala’s publicly funded primary care system. The registry describes the study objective as assessing feasibility and acceptability. The study was sponsored by the University of Michigan.

The registry describes a 6-month trial in 11 Ministry of Health primary care facilities, starting in October 2023. The study record gives a start date of 2023-10-03 and a primary completion date of 2024-05-27. Enrollment was 964. The record describes a patient group whose health markers would be monitored and a provider group administering care to patient participants. These groups represent different participant roles; they are not a treatment group and a comparable untreated control group.

Random allocation and masking were not used: the allocation is listed as non-randomized and masking as none. Because there was no randomized comparison, differences between the patient and provider groups would not estimate a treatment effect. The registry record does not report a separate control condition or a comparative effectiveness design.

The primary outcome was provider feasibility measured with the Feasibility of Intervention Measure questionnaire at 6 months. The registry also lists secondary outcomes relating to treatment rates, clinical control, adoption, and fidelity. The outcome descriptions and labels do not, by themselves, provide observed results. The primary score, secondary outcome estimates, and analyses 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: Providers not considered Enrolled

Overall Study

Analysis population for the primary outcome, as defined in the registry: This outcome measure only applies to the Providers group. No data was collected for the Patients group. Only 20 providers responded to this survey.

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 Score on Feasibility of Intervention Measure (FIM) Questionnaire, measured over 6 months.

The primary endpoint was the score on the Feasibility of Intervention Measure questionnaire at 6 months. It was intended to assess feasibility among Ministry of Health participants, and the registry specifies that it applies only to the providers group. The record says a Spanish-language version of the questionnaire would be adapted for the project and that semi-structured interviews would also be used to assess feasibility. Only the questionnaire score is identified as the primary outcome.

The questionnaire has four items. Scores are described on a scale from 1 to 5, with 1 the worst and 5 the best. The average score for each participant was to be used. In general, a feasibility measure addresses whether an intervention can be implemented in its intended setting; it does not directly establish clinical benefit. The registry does not report the providers’ score, its variability, or findings from the interviews.

The registry states that only 20 providers responded to the survey and that no data were collected for the patient group for this outcome. That makes the endpoint specifically a provider-reported implementation measure, not a patient-level clinical outcome. Without the observed score and its distribution, the registry record does not show how respondents rated feasibility or how consistently they responded.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a non-randomized, single-group implementation study. This design is suited to describing implementation activity and outcomes in the participating setting, but it does not create a randomized counterfactual. In general, a randomized control group helps distinguish an intervention’s effect from changes that could occur over time or for other reasons. The registry record does not describe such a group or a method for making a causal comparison.

What does the primary measure capture?

The primary outcome is a provider questionnaire score intended to measure feasibility. The record says the Spanish-language version would be adapted for the project, and that the average score for each participant would be used. This is a participant-level summary of questionnaire responses. The registry does not report how questionnaire items were handled when responses were missing, or whether any additional scoring rules were used. Although semi-structured interviews are named as another feasibility assessment, interview findings or an analysis method are not reported in the registry record.

How should a median and inter-quartile range be understood?

The primary outcome is specified as a median with an inter-quartile range. In general, the median describes the midpoint of an ordered set of observed scores. The inter-quartile range describes the spread of the middle portion of those scores. These summaries can be useful when a distribution is skewed or when values are bounded, as the questionnaire scale is. They do not show every response, and the same median can occur with different distributions. Here, the observed median and inter-quartile range are not reported in the registry record, so the provider responses cannot be summarized from the posted result information.

What does the respondent count establish?

The registry reports that 20 providers responded to the primary questionnaire and that the outcome did not apply to the patient group. This identifies the number of survey respondents, but does not establish how many providers were eligible, how many were approached, or how many completed every item. Those details are not reported in the registry record. In general, the extent and pattern of nonresponse matter because respondents may differ from nonrespondents. Without information about nonresponse or missing items, the scope of inference from the provider responses cannot be fully evaluated.

What can the listed secondary outcomes tell readers?

The registry lists treatment rates, glycemic control, blood-pressure control, adoption, and fidelity domains among the secondary outcomes. These outcomes cover clinical care processes, patient measures, and implementation. A list of intended measures is not evidence that an outcome changed. The record reports 19 outcome measures but 0 analyses, and numerical results for these secondary outcomes are not reported in the registry record. The specific analysis populations, time-point comparisons, and statistical methods for these outcomes are also not reported in the registry record.

In general, estimates of rates or proportions depend on clear definitions of the numerator and denominator, as well as the population assessed. Repeated measurements may require methods that account for the fact that observations from the same participant are related. No definitions or modeling details for such analyses are reported in the registry record. It is therefore not possible to determine from the posted information how repeated measures, clustering by facility, or incomplete observations were handled.

What does the design imply for interpretation?

Because allocation was non-randomized and the study is described as single-group, the record does not support a randomized between-group treatment-effect interpretation. General statistical reasoning distinguishes an observed outcome in an implementation study from an estimate of what would have happened under a different intervention. Without a comparable control condition, that counterfactual is not directly observed. The registry record does not report an alternative comparison or adjustment strategy.

The record includes a description of assumptions for sample-size planning illustrations: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with an effect defined as a fraction of an observed effect. Those are planning assumptions, not a description of the study’s single-group design. The record also states that such illustrations are not the trial’s own design. No sample-size justification or statistical analysis plan for the trial is reported in the registry record. Planning calculations should not be read as observed power or as evidence that an effect was detected.

In general, an interval estimate expresses uncertainty around an estimate, while a hypothesis test addresses compatibility with a specified null model under its assumptions. Neither can be interpreted without the relevant estimate, method, and analysis population. The registry record reports no analyses, p-values, or confidence intervals. Thus, no inferential finding can be reconstructed from the posted information.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 19 outcome measures, including a primary feasibility measure and secondary measures of treatment, clinical control, adoption, and fidelity. When several outcomes are assessed, multiplicity can matter: in general, the chance of at least one apparently unusual result can increase when many separate tests are conducted. Whether and how to address this depends on the analysis plan and the purpose of each outcome. A multiplicity strategy is not reported in the registry record, and the record lists 0 analyses. No claim about statistical significance across the outcomes can be made.

The primary outcome was restricted to providers, with 20 survey respondents; the record says no patient data were collected for this outcome. The registry does not report the number of providers eligible or invited, item-level completion, or how missing responses were handled. Missing-data methods and assumptions are not reported in the registry record. In general, missingness can affect both the estimate and its uncertainty, especially if the likelihood of responding is related to a participant’s experience.

The analysis populations are not reported in the registry record. It is therefore unclear which participants contributed to each listed secondary measure, how denominators were defined, or whether all enrolled participants were included in each analysis. The record also does not report an analysis plan, a prespecified hierarchy among secondary outcomes, or methods for repeated observations. These omissions prevent assessment of whether analysis choices were prespecified and how incomplete data or multiple outcomes were addressed.

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 reports 0 serious adverse events among 964 patients listed as at risk, and 0 other adverse events among the same 964 patients listed as at risk. It records 0 deaths in the patient group. For providers, the registry lists 0 participants at risk for both serious and other adverse events, 0 events, and 0 deaths.

These figures should be read as the registry’s reported counts, not as proof that no safety events occurred outside the recorded monitoring or reporting process. The provider group’s at-risk count is 0, so its zero event count does not represent safety observations among a provider denominator. The registry record does not provide event descriptions, ascertainment procedures, exposure details, or a comparative safety analysis.

In general, adverse-event counts describe events recorded under a study’s monitoring and reporting definitions. They do not by themselves establish whether an event was caused by an intervention. The listed patient counts provide a denominator for the recorded patient group, but no comparative control group is described. The safety figures therefore do not support a comparative estimate or a causal conclusion.

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

The registry record documents a pilot of integrated diabetes and hypertension management based on the HEARTS model in 11 Ministry of Health primary care facilities in Guatemala. Its stated objective was to assess feasibility and acceptability in the publicly funded primary care system. The primary outcome was a provider feasibility questionnaire at 6 months, and the registry reports that 20 providers responded.

The record does not report the primary questionnaire score, the inter-quartile range, interview findings, or statistical analyses. It also lists 19 outcome measures and 0 analyses. The secondary outcome labels identify areas of interest, but no numerical findings are reported for them. These omissions mean the registry record cannot establish how feasible providers found the model, whether clinical measures changed, or whether implementation was adopted with fidelity.

The design does not include a randomized control group. The patient and provider groups are not interchangeable comparison arms: they represent distinct roles and different outcome information. Accordingly, the record does not support a causal comparison between them. General statistical interpretation of implementation outcomes also depends on their definitions, denominators, missing-data handling, and analysis methods, which are not reported in the registry record.

The event counts describe what was entered for adverse events, with 0 serious and 0 other events among the 964 patients listed at risk, and no providers listed as at risk. Those entries do not establish comparative safety or causation.

In short, the registry provides a design and measurement description, but not the outcome results needed to assess the pilot’s findings. Absence of a reported result is not evidence that the result was favorable, unfavorable, or null.

13. Why This Trial Matters Statistically

Implementation studies ask questions that differ from whether an intervention changes a clinical endpoint under controlled conditions. Feasibility and acceptability can help characterize whether a model can be delivered in a particular care system. The registry’s focus on integrating diabetes and hypertension management into HEARTS implementation in Guatemala therefore concerns both the care model and the context in which it was introduced.

The primary measure is provider-reported feasibility, while the listed secondary outcomes span treatment rates, clinical control, adoption, and fidelity. These domains are related but not interchangeable. A feasibility score would describe provider responses; clinical indicators would describe patient outcomes or care processes; fidelity measures would address implementation. Each requires its own outcome definition and appropriate analysis population.

The design matters statistically because a single-group, non-randomized pilot cannot provide the same kind of causal contrast as a randomized trial. It can describe what was measured among participants in the implementation setting, but without a comparable control condition, changes cannot be attributed uniquely to the model. That distinction is important when readers interpret clinical or implementation outcomes.

The registry record states that 20 providers responded to the primary survey, but does not report the score or analysis. It also lists 19 outcome measures and 0 analyses. This makes the record useful for identifying the intended questions and the limits of the available reporting, while leaving the substantive outcome findings unavailable. It illustrates why reporting observed estimates, uncertainty, denominators, and analysis methods is essential for evaluating implementation research.

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 consequential limitation for interpreting this registry entry is that the primary outcome result is not reported in the registry record. The score and inter-quartile range are absent, as are the findings from the semi-structured interviews. The record therefore describes how feasibility was intended to be assessed without showing what respondents reported.

The primary questionnaire was provider-only. The registry reports 20 provider respondents and no patient data for that endpoint, but does not report how many providers were eligible or invited, whether all items were completed, or how respondents were selected. The representativeness of those responses cannot be assessed from the record.

The study is described as non-randomized and single-group, with no masking. The patient and provider groups have different roles and cannot serve as like-for-like controls. This constrains causal interpretation even if outcome results were available. The registry does not report a comparison method or a statistical adjustment plan.

The record lists secondary outcomes, but numerical results and analyses are not reported. It does not specify analysis populations, outcome denominators, missing-data procedures, or methods for handling repeated observations or facility-level structure. The registry also does not report a multiplicity approach or the trial’s statistical analysis plan.

Finally, adverse-event information is limited to counts and at-risk numbers. No event descriptions or ascertainment details are reported, and no providers are listed as at risk. These registry limitations restrict conclusions about safety as well as effectiveness and implementation outcomes.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Implementing HEARTS in Guatemala — NCT06080451.
• Registry record last updated 2025-06-19; status last verified 2025-06.
• Results first posted 2025-06-19.
• 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

NCT06080451, titled Implementing HEARTS in Guatemala, is a completed, non-randomized, single-group pilot sponsored by the University of Michigan. It evaluated integrated diabetes and hypertension management based on the HEARTS model in 11 Ministry of Health primary care facilities. Enrollment was 964, with a recorded start date of 2023-10-03 and primary completion date of 2024-05-27.

The primary outcome was provider feasibility measured by questionnaire at 6 months. The registry reports 20 provider survey respondents and no patient data for that outcome. It lists 19 outcome measures and 0 analyses. The primary score, secondary results, and analysis methods are not reported in the registry record. The patient group has 0 reported serious adverse events and 0 other adverse events among 964 listed at risk; providers are listed with 0 at risk.