NCT06080451

Implementing HEARTS in Guatemala

Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 964 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n=45), hypertension (n=45), or both (n=10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on Healthy-lifestyle counseling and Evidence-based treatment protocols; strengthening Access to medications and diagnostics; training on Risk-based cardiovascular disease management; Team-based care and task sharing; and Systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control) and key implementation outcomes (adoption, fidelity, usability, and sustainability).

Conditions

• Diabetes Mellitus, Type 2
• Hypertension
• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	Integrated Diabetes and Hypertension Primary Care Model	The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. 1. Training health workers on diabetes and hypertension treatment protocols 2. Team-based care and task sharing 3. Strengthening access to medications and diagnostics 4. Electronic medical record system and registry 5. Systems monitoring and feedback of key indicators
OTHER	Integrated Diabetes and Hypertension Primary Care Model - Providers	The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. 1. Training health workers on diabetes and hypertension treatment protocols 2. Team-based care and task sharing 3. Strengthening access to medications and diagnostics 4. Electronic medical record system and registry 5. Systems monitoring and feedback of key indicators Health care providers will administer this intervention to patient participants and will report on their experience.

Timeline

• Start date: 2023-10-03
• Primary completion: 2024-05-27
• Completion: 2024-05-27
• First posted: 2023-10-12
• Last updated: 2025-06-19
• Results posted: 2025-06-19

Locations

1 site across 1 country: Guatemala