Implementing HEARTS in Guatemala

University of Michigan

Status: Completed

Conditions: Hypertension; Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Other: Integrated Diabetes and Hypertension Primary Care Model - Providers; Other: Integrated Diabetes and Hypertension Primary Care Model

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06080451

K23HL161271 (U.S. NIH Grant/Contract)

HUM00234613

Details and patient eligibility

About

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.

Full 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=45), hypertension (n=45), or both (n=10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on Healthy-lifestyle counseling and Evidence-based treatment protocols; strengthening Access to medications and diagnostics; training on Risk-based cardiovascular disease management; Team-based care and task sharing; and Systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control) and key implementation outcomes (adoption, fidelity, usability, and sustainability).

Enrollment: 964 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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964 participants in 2 patient groups

HEARTS implementation - Patients

Experimental group

Description:

A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.

Treatment:

Other: Integrated Diabetes and Hypertension Primary Care Model

HEARTS implementation - Providers

Experimental group

Description:

A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.

Treatment:

Other: Integrated Diabetes and Hypertension Primary Care Model - Providers