Implementing HEARTS in Guatemala

NCT ID: NCT06080451

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 964 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2024-05-27

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 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.

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=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).

Conditions

Diabetes Mellitus, Type 2; Hypertension; Cardiovascular Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HEARTS implementation - Patients

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.

Group Type: EXPERIMENTAL

Integrated Diabetes and Hypertension Primary Care Model

Intervention Type: OTHER

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

HEARTS implementation - Providers

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.

Group Type: EXPERIMENTAL

Integrated Diabetes and Hypertension Primary Care Model - Providers

Intervention Type: OTHER

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.

Interventions

Integrated Diabetes and Hypertension Primary Care Model

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

Intervention Type: OTHER

Integrated Diabetes and Hypertension Primary Care Model - Providers

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.

Intervention Type: OTHER

Other Intervention Names

HEARTS

Eligibility Criteria

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

• Participation in delivering HEARTS or on the Technical Advisory Committee

Exclusion Criteria

• Confirmed or suspected type 1 diabetes
• Pregnant
• Are not managed at MOH health centers or health posts

Provider/other participants

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Institute of Nutrition of Central America and Panama

OTHER

Sponsor Role: collaborator

Ministry of Health, Guatemala

OTHER_GOV

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

David Flood

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Flood, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Ministry of Health clinics

San Pablo La Laguna, Departamento de Sololá, Guatemala

Countries

Guatemala

References

Wellmann IA, Ayala LF, Rodriguez JJ, Guetterman TC, Irazola V, Palacios E, Huffman MD, Rohloff P, Heisler M, Ramirez-Zea M, Flood D. Implementing integrated hypertension and diabetes management using the World Health Organization's HEARTS model: protocol for a pilot study in the Guatemalan national primary care system. Implement Sci Commun. 2024 Jan 9;5(1):7. doi: 10.1186/s43058-023-00539-8.

Reference Type: BACKGROUND

PMID: 38195600 (View on PubMed)

Wellmann IA, Ayala LF, Valley TM, Irazola V, Huffman MD, Heisler M, Rohloff P, Donis R, Palacios E, Ramirez-Zea M, Flood D. Evaluating the World Health Organization's Hearts Model for Hypertension and Diabetes Management: A Pilot Implementation Study in Guatemala. Glob Heart. 2025 Jan 31;20(1):9. doi: 10.5334/gh.1397. eCollection 2025.

Reference Type: RESULT

PMID: 39896314 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23HL161271

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00234613

Identifier Type: -

Identifier Source: org_study_id