Implementing HEARTS in Guatemala

NCT06080451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 964

Last updated 2025-06-19

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Institute of Nutrition of Central America and Panama

    collaborator OTHER
  • Ministry of Health, Guatemala

    collaborator OTHER_GOV
  • University of Michigan

    lead OTHER

Principal Investigators

  • David Flood, MD · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2024-05-27
Completion
2024-05-27

Countries

  • Guatemala

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06080451 on ClinicalTrials.gov