Trial results for a study implementing the HEARTS technical package for integrated management of Type 2 Diabetes, hypertension, and cardiovascular diseases in Guatemala were posted on 2025-06-19. The study reported median feasibility and acceptability scores of 5.0 among providers, with 41 percent of patient participants achieving glycemic control.
Background
The HEARTS Technical Package, developed by the World Health Organization, aims to bridge the gap in cardiovascular disease prevention and management in low- and middle-income countries. Guatemala, a middle-income country, is currently implementing HEARTS. National health authorities expressed interest in exploring how hypertension and diabetes management could be integrated into the broader HEARTS implementation framework. This study was designed as a feasibility and acceptability pilot to test an integrated management approach for hypertension and diabetes within Guatemala's publicly funded primary care system.
Trial design
This completed study, identified as Phase NA, enrolled 964 participants. The trial focused on patients with Diabetes Mellitus, Type 2, Hypertension, and Cardiovascular Diseases. The objective was to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on the HEARTS framework in primary care settings in Guatemala. The intervention involved implementing the HEARTS technical package with a specific focus on integrating care for these chronic conditions.
Key results
The trial results highlighted several key measurements related to the implementation and patient outcomes:
- The median score on the Feasibility of Intervention Measure (FIM) Questionnaire for providers was 5.0 on a scale.
- The median score on the Acceptability of Intervention Measure (AIM) Questionnaire for providers was 5.0 on a scale.
- 2 target health districts met their enrollment goals for patients.
- The proportion of patient participants with a subsequent follow-up visit within 3 months was 36 percentage of patients.
- The hypertension treatment rate included 197 Participants.
- The diabetes treatment rate included 108 Participants.
- The proportion of patient participants achieving glycemic control was 41 percent.
- The proportion achieving control of blood pressure was 50.6 percent.
- Adoption of the program was observed in 10 Clinics.
- Fidelity in health worker training involved 20 Participants.
- Fidelity in team-based care and task sharing was observed in 10 Clinics.
What this means
The high median scores for feasibility and acceptability among providers suggest that the integrated HEARTS approach for managing hypertension and Type 2 Diabetes is well-received and practical within Guatemala's primary care system. The achievement of glycemic control in 41 percent of patients and blood pressure control in 50.6 percent indicates a positive impact on clinical outcomes, demonstrating the potential effectiveness of this integrated model. The successful enrollment in 2 districts, patient follow-up rates, and clinic adoption figures further support the viability of scaling such integrated care programs to address chronic non-communicable diseases in similar settings.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06080451, titled "Implementing HEARTS in Guatemala", were posted on 2025-06-19 on clinicaltrials.gov.