Status:

COMPLETED

Implementing HEARTS in Guatemala

Lead Sponsor:

University of Michigan

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Institute of Nutrition of Central America and Panama

Conditions:

Diabetes Mellitus, Type 2

Hypertension

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 m...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 3 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 27 2024

    Estimated Enrollment :

    964 Patients enrolled

    Trial Details

    Trial ID

    NCT06080451

    Start Date

    October 3 2023

    End Date

    May 27 2024

    Last Update

    June 19 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Ministry of Health clinics

    San Pablo La Laguna, Departamento de Sololá, Guatemala