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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1
Ministry of Health clinics
San Pablo La Laguna, Departamento de Sololá, Guatemala