Implementing HEARTS in Guatemala

NCT06080451 | Completed Results

• 2 other identifiers: HUM00234613K23HL161271
• Study Type: interventional
• Target: 964
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

• Score on Feasibility of Intervention Measure (FIM) Questionnaire

  Feasibility will be assessed among Ministry of Health (MOH) participants through the four-item Feasibility of Intervention Measure (FIM) Questionnaire and semi-structured interviews. A Spanish-language version of the FIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.

  6 months

• Number of Target Health Districts That Met Enrollment Goals

  This study will be working with two different health districts, one in the west and the other in the east. This measure is the number of districts that met enrollment goals for patients for patients with diabetes (at least 25) and also for patients with hypertension (at least 25). A given patient may have both diabetes and hypertension and thus count toward each benchmark

  6 months

• Score on Acceptability of Intervention Measure (AIM) Questionnaire

  Acceptability will be assessed among providers through the four-item Acceptability Intervention Measure (AIM) Questionnaire and semi-structured interviews. A Spanish-language version of the AIM will be adapted for this project. Scores will be on a scale of 1 to 5, with 1 being the worst and 5 being the best. The average score for each participant will be used.

  6 months

• Proportion of Patient Participants With Subsequent Follow-up Visit Within 3 Months

  Proportion of patient participants with subsequent follow-up visit within 3 months in both regions combined.

  3 months

Secondary Outcomes (15)

• Hypertension Treatment Rate

  6 months

• Diabetes Treatment Rate

  6 months

• Proportion of Patient Participants Achieving Glycemic Control

  6 months

• Proportion Achieving Control of Blood Pressure

  6 months

• Adoption

  6 months

Study Arms (2)

HEARTS implementation - Patients

EXPERIMENTAL

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.

Other: Integrated Diabetes and Hypertension Primary Care Model

HEARTS implementation - Providers

EXPERIMENTAL

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.

Other: Integrated Diabetes and Hypertension Primary Care Model - Providers

Interventions

Integrated Diabetes and Hypertension Primary Care Model 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

Also known as: HEARTS

HEARTS implementation - Patients

Integrated Diabetes and Hypertension Primary Care Model - Providers 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.

HEARTS implementation - Providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-pregnant adults aged ≥18 years
• Diagnoses of type 2 diabetes or hypertension
• Present for routine care at participating MOH primary health facilities

You may not qualify if:

• Confirmed or suspected type 1 diabetes
• Pregnant
• Are not managed at MOH health centers or health posts
• Provider/other participants
• Participation in delivering HEARTS or on the Technical Advisory Committee
• None

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Institute of Nutrition of Central America and Panama: collaborator
• Ministry of Health, Guatemala: collaborator

Study Sites (1)

Ministry of Health clinics

San Pablo La Laguna, Departamento de Sololá, Guatemala

Location

Related Publications (2)

• 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.

  PMID: 38195600 BACKGROUND

• 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.

  PMID: 39896314 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Cardiovascular Diseases

Interventions

Heart, Artificial

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Artificial Organs; Surgical Equipment

Results Point of Contact

• Title: Dr. David Flood
• Organization: University of Michigan

dcflood@umich.edu

734-647-2892

Study Officials

• David Flood, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: October 3, 2023
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: June 19, 2025
• Results First Posted: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

GU (1)