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Completed

NCT Number: NCT06080451

Implementing HEARTS in Guatemala

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health clinics

San Pablo La Laguna, Departamento de Sololá, Guatemala

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

  • 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

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.

  • 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.

Primary outcomes

  1. Score on Feasibility of Intervention Measure (FIM) Questionnaire

    Time frame: 6 months

    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.

  2. Number of Target Health Districts That Met Enrollment Goals

    Time frame: 6 months

    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

  3. Score on Acceptability of Intervention Measure (AIM) Questionnaire

    Time frame: 6 months

    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.

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

    Time frame: 3 months

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

Secondary outcomes

  1. Hypertension Treatment Rate

    Time frame: 6 months

    Number of patients receiving hypertension medication treatment in the 6th month of the study.

  2. Diabetes Treatment Rate

    Time frame: 6 months

    Number of patients receiving diabetes medication treatment in the 6th month of the trial..

  3. Proportion of Patient Participants Achieving Glycemic Control

    Time frame: 6 months

    Proportion achieving glycemic control (fasting blood glucose <115 mg/dl or random blood glucose <160 mg/dl) among patients with diabetes

  4. Proportion Achieving Control of Blood Pressure

    Time frame: 6 months

    Proportion achieving control of blood pressure (<130/80 mmHg) among patients with hypertension. This information will be taken from electronic medical records.

  5. Adoption

    Time frame: 6 months

    Count and percentage of participating health facilities who enrolled at least one patient with hypertension or diabetes.

  6. Fidelity - Health Worker Training

    Time frame: 6 months

    Number of health workers in each district attending all training sessions

  7. Fidelity - Team-based Care and Task Sharing

    Time frame: 6 months

    Proportion of primary health facilities conducting at least one care coordination meeting

  8. Fidelity - Access to Medicines and Diagnostics

    Time frame: 6 months

    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)).

  9. Fidelity - Facility-based Electronic Monitoring Tool

    Time frame: 6 months

    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.

  10. Usability

    Time frame: 6 months

    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.

  11. Sustainability

    Time frame: 6 months

    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.

  12. Mean Systolic Blood Pressure

    Time frame: 6 months

    Mean systolic blood pressure among patients with hypertension

  13. Mean Diastolic Blood Pressure

    Time frame: 6 Months

    Mean diastolic blood pressure among patients with hypertension

  14. Fidelity - Chart Audit

    Time frame: 6 months

    Proportion of clinical visits that are guideline concordant according to study team's audit of least 25% of patient visits

  15. Fidelity - Systems Monitoring and Feedback

    Time frame: 6 months

    Proportion of quarterly reports viewed by health district administrators

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Institute of Nutrition of Central America and Panama
  • Ministry of Health, Guatemala
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2023
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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