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Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation

NCT07536919 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1440

Last updated 2026-04-17

No results posted yet for this study

Summary

The purpose of this study is to find out whether a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care clinics deliver better treatment. It includes training for health workers, simpler treatment guides, better access to medicines, teamwork among clinic staff, and tracking systems to monitor patient care. In this study, 36 public primary care clinics in Guatemala will be randomly assigned to either use the HEARTS program or continue with their current care. About 1,440 adults who have both high blood pressure and diabetes will take part. Participants will be assessed at the start of the study and again after 12 months. The main measures are blood pressure and hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months).

Conditions

Interventions

OTHER

HEARTS implementation strategies

A package of five multilevel implementation strategies based on the WHO/PAHO Hearts Technical Package, adapted to Guatemala: (1) Training and supportive supervision for health workers on evidence-based hypertension and diabetes treatment protocols; (2) Simplifying treatment protocols; (3) Strengthening supply chains of a core set of medications and supplies; (4) Task sharing with non-physician health workers; (5) Implementing quality monitoring systems using standardized registries and indicators.

OTHER

Supply chain strengthening

Strengthening supply chains of a core set of medications and supplies for hypertension and diabetes care. This strategy is provided to both arms to ensure that observed between-arm differences are attributable to the other HEARTS implementation strategies rather than to variations in medication and supply availability.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-05-01
Primary Completion
2030-05-01
Completion
2030-05-01

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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 NCT07536919 on ClinicalTrials.gov