N/A
Completed N=1,004
Implementing HEARTS in Guatemala
Source: ClinicalTrials.gov NCT06080451 ↗Enrolled (actual)
1,004
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Score on Feasibility of Intervention Measure (FIM) Questionnaire — 5.0 score on a scale
Summary
The HEARTS Technical Package was developed by the World Health Organization to address the implementation gap of cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on Feasibility of Intervention Measure (FIM) Questionnaire |
5.0 | — |
| PRIMARY Number of Target Health Districts That Met Enrollment Goals |
2 | — |
| PRIMARY Score on Acceptability of Intervention Measure (AIM) Questionnaire |
5.0 | — |
| PRIMARY Proportion of Patient Participants With Subsequent Follow-up Visit Within 3 Months |
36 | — |
| SECONDARY Hypertension Treatment Rate |
197 | — |
| SECONDARY Diabetes Treatment Rate |
108 | — |
| SECONDARY Proportion of Patient Participants Achieving Glycemic Control |
41 | — |
| SECONDARY Proportion Achieving Control of Blood Pressure |
50.6 | — |
| SECONDARY Adoption |
10 | — |
| SECONDARY Fidelity - Health Worker Training |
20; 20 | — |
| SECONDARY Fidelity - Team-based Care and Task Sharing |
10 | — |
| SECONDARY Fidelity - Access to Medicines and Diagnostics |
49 | — |
| SECONDARY Fidelity - Facility-based Electronic Monitoring Tool |
7.6 | — |
| SECONDARY Usability |
67.7 | — |
| SECONDARY Sustainability |
5.3 | — |
| SECONDARY Mean Systolic Blood Pressure |
141.7 | — |
| SECONDARY Mean Diastolic Blood Pressure |
81.5 | — |
| SECONDARY Fidelity - Chart Audit |
— | — |
| SECONDARY Fidelity - Systems Monitoring and Feedback |
— | — |
Eligibility Criteria
Patient participants
Inclusion criteria
- Non-pregnant adults aged ≥18 years
- Diagnoses of type 2 diabetes or hypertension
- Present for routine care at participating MOH primary health facilities
Exclusion criteria
- Confirmed or suspected type 1 diabetes
- Pregnant
- Are not managed at MOH health centers or health posts
Provider/other participants
Inclusion criteria
- Participation in delivering HEARTS or on the Technical Advisory Committee
Exclusion criteria
- None
Data sourced from ClinicalTrials.gov (NCT06080451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.