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Diabetes Mellitus, Type 2NCT06080451

Implementing HEARTS in Guatemala

A study testing Integrated Diabetes and Hypertension Primary Care Model and Integrated Diabetes and Hypertension Primary Care Model - Providers in people with Diabetes Mellitus, Type 2 and Hypertension, run by University of Michigan at 1 site in Guatemala.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Integrated Diabetes and Hypertension Primary Care Model and Integrated Diabetes and Hypertension Primary Care Model - Providers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
964 participants
Where
1 siteGuatemala
Study dates
3 Oct 2023to 27 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Confirmed or suspected type 1 diabetes
  • Pregnant
  • Are not managed at MOH health centers or health posts
  • Provider/other participants
  • None

Trial locations and contacts

1 site in 1 country.

Guatemala1 site

  • Ministry of Health clinics

    San Pablo La Laguna, Departamento de Sololá

Other trials in Guatemala

About this study

Official title: 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.

Read the 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).

Being tested
Integrated Diabetes and Hypertension Primary Care Model, Integrated Diabetes and Hypertension Primary Care Model - Providers
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Diabetes and Hypertension Primary Care ModelOther

    Also called HEARTS

    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

  • Integrated Diabetes and Hypertension Primary Care Model - ProvidersOther

    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.

Study groups in NCT06080451
Study groupRoleWhat they receive
HEARTS implementation - PatientsExperimentalA 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.
Receives: Other: Integrated Diabetes and Hypertension Primary Care Model
HEARTS implementation - ProvidersExperimentalA 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.
Receives: Other: Integrated Diabetes and Hypertension Primary Care Model - Providers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 3 months

Secondary outcomes (15)

  1. Hypertension Treatment Rate

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

    Measured: 6 months

  2. Diabetes Treatment Rate

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

    Measured: 6 months

  3. 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

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. Adoption

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

    Measured: 6 months

  6. Fidelity - Health Worker Training

    Number of health workers in each district attending all training sessions

    Measured: 6 months

  7. Fidelity - Team-based Care and Task Sharing

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

    Measured: 6 months

  8. 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)).

    Measured: 6 months

  9. 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.

    Measured: 6 months

  10. 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.

    Measured: 6 months

  11. 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.

    Measured: 6 months

  12. Mean Systolic Blood Pressure

    Mean systolic blood pressure among patients with hypertension

    Measured: 6 months

  13. Mean Diastolic Blood Pressure

    Mean diastolic blood pressure among patients with hypertension

    Measured: 6 Months

  14. Fidelity - Chart Audit

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

    Measured: 6 months

  15. Fidelity - Systems Monitoring and Feedback

    Proportion of quarterly reports viewed by health district administrators

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start3 Oct 2023
  3. Primary completion27 May 2024
  4. Study completion27 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
964 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06080451
Sponsor's protocol ID
HUM00234613
Other IDs
K23HL161271
Status last verified
Jun 2025
First submitted
6 Oct 2023
Last updated
19 Jun 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 38195600

  • 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.

    PubMed 39896314

  • Valley TM, Santizo-Malafronti C, Wellmann IA, Ayala LF, Lucas N, Huffman MD, Chary A, Rohloff P, Donis R, Nufio AIAA, Ramirez-Zea M, Flood D. Understanding implementation of HEARTS for hypertension and diabetes in Guatemala: Qualitative and mixed-methods pilot results. medRxiv [Preprint]. 2026 May 6:2026.05.04.26352395. doi: 10.64898/2026.05.04.26352395.

    PubMed 42145591

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Diabetes and Hypertension Primary Care Model and Integrated Diabetes and Hypertension Primary Care Model - Providers in people with Diabetes Mellitus, Type 2 and Hypertension, run by University of Michigan at 1 site in Guatemala.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score on Feasibility of Intervention Measure (FIM) Questionnaire (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06080451, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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Implementing HEARTS in Guatemala (NCT06080451) | AzTrials