CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 964 enrolled
Drug / intervention
Integrated Diabetes and Hypertension Primary Care Model +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT06080451N/ACompleted
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Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model

University of Michigan·interventional·Posted Oct 12, 2023·Updated Jun 19, 2025

In Brief

A clinical study evaluating Integrated Diabetes and Hypertension Primary Care Model and Integrated Diabetes and Hypertension Primary Care Model - Providers for Diabetes Mellitus, Type 2 and 2 related conditions. Completed, enrolled 964 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases
CountriesGuatemala
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Institute of Nutrition of Central America and Panama, Ministry of Health, Guatemala

Timeline

N/ACompletedFinished
202420252026
First PostedOct 12, 2023
Enrollment StartOct 3, 2023
Primary CompletionMay 27, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.7 years ago

Interventions

Integrated Diabetes and Hypertension Primary Care Modelother

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

Integrated Diabetes and Hypertension Primary Care Model - Providersother

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.