Implementing HEARTS in Guatemala

Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Integrated Diabetes and Hypertension Primary Care Model; Other: Integrated Diabetes and Hypertension Primary Care Model - Providers

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).

• Study Type: Interventional
• Enrollment (Actual): 964
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guatemala
  • Sololá
    • San Pablo, Sololá, Guatemala
      • Ministry of Health Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Training health workers on diabetes and hypertension treatment protocols; Team-based care and task sharing; Strengthening access to medications and diagnostics; Electronic medical record system and registry; Systems monitoring and feedback of key indicators; Other Names: HEARTS
Experimental: 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.	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.; Training health workers on diabetes and hypertension treatment protocols; Team-based care and task sharing; Strengthening access to medications and diagnostics; Electronic medical record system and registry; Systems monitoring and feedback of key indicators Health care providers will administer this intervention to patient participants and will report on their experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypertension Treatment Rate	Number of patients receiving hypertension medication treatment in the 6th month of the study.	6 months
Diabetes Treatment Rate	Number of patients receiving diabetes medication treatment in the 6th month of the trial..	6 months
Proportion of Patient Participants Achieving Glycemic Control	Proportion achieving glycemic control (fasting blood glucose <115 mg/dl or random blood glucose <160 mg/dl) among patients with diabetes	6 months
Proportion Achieving Control of Blood Pressure	Proportion achieving control of blood pressure (<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records.	6 months
Adoption	Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes.	6 months
Fidelity - Health Worker Training	Number of health workers in each district attending all training sessions	6 months
Fidelity - Team-based Care and Task Sharing	Proportion of primary health facilities conducting at least one care coordination meeting	6 months
Fidelity - Access to Medicines and Diagnostics	Months in which primary health facilities had monthly availability of Ministry of Health medications and diagnostics for diabetes and hypertension. Drugs include antihypertensive medications (hydrochlorothiazide, enalapril, losartan) and oral hypoglycemic agents (metformin and glimepiride). Diagnostics including blood pressure cuffs and monitors, glucometers, lancets, and glucose strips. Data is reported in "clinic-months", which is the sum number of months that each clinic reported monthly availability of medications and diagnostics (n=60 total clinic months(10 clinics x 6 months)).	6 months
Fidelity - Facility-based Electronic Monitoring Tool	Proportion of patient visits captured in DHIS2 during the study compared to comprehensive records in the Ministry of Health's Health Management Information System. Data was collected at the end of the 6th month study. Data is presented as percent of visits that were captured.	6 months
Usability	Average score on the System Usability Scale questionnaire. Scores have a range of 0 (worst) to 100 (best). Questionnaire was given to the provider arm only.	6 months
Sustainability	Mean score on a sustainability questionnaire. Questionnaire was created by combining 6 questions from the Program Sustainability Assessment Tool (PSAT) and Clinical Sustainability Assessment Tools (CSAT). Scores range from 1 (worst) to 7 (best). The data reported is the median of the mean scores for each of the health providers.	6 months
Mean Systolic Blood Pressure	Mean systolic blood pressure among patients with hypertension	6 months
Mean Diastolic Blood Pressure	Mean diastolic blood pressure among patients with hypertension	6 Months
Fidelity - Chart Audit	Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits	6 months
Fidelity - Systems Monitoring and Feedback	Proportion of quarterly reports viewed by health district administrators	6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Institute of Nutrition of Central America and Panama; Ministry of Health, Guatemala
• Investigators: Principal Investigator: David Flood, MD, University of Michigan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): May 27, 2024
• Study Completion (Actual): May 27, 2024

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hypertension; Diabetes Mellitus, Type 2; Cardiovascular Diseases
• Other Study ID Numbers: HUM00234613; K23HL161271 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This project will produce multiple types of data, including patients' clinical information, health facility assessments, and structured and semi-structured interviews. Deidentified data, analytic code, and data dictionaries will be made available on the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) data repository (https://biolincc.nhlbi.nih.gov/) after the study concludes. Semi-structured interview transcripts and structured questionnaire data will not be shared due to privacy concerns and risk for re-identification.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No