Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation

NCT07536919 | Not Yet Recruiting DMC

• 1 other identifier: HL183254
• Study Type: interventional
• Target: 1,440
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to find out whether a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care clinics deliver better treatment. It includes training for health workers, simpler treatment guides, better access to medicines, teamwork among clinic staff, and tracking systems to monitor patient care. In this study, 36 public primary care clinics in Guatemala will be randomly assigned to either use the HEARTS program or continue with their current care. About 1,440 adults who have both high blood pressure and diabetes will take part. Participants will be assessed at the start of the study and again after 12 months. The main measures are blood pressure and hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months).

Conditions

Hypertension (HTN); Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Change in systolic blood pressure

  Between-arm mean difference in change in systolic blood pressure (mmHg)

  Enrollment to 12 months

• Change in hemoglobin A1c

  Between-arm mean difference in change in hemoglobin A1c (%)

  Enrollment to 12 months

Secondary Outcomes (4)

• Change in diastolic blood pressure

  Enrollment to 12 months

• Proportion with blood pressure control

  Enrollment to 12 months

• Proportion with hemoglobin A1c control

  12 months

• Proportion with combined blood pressure and hemoglobin A1c control

  12 months

Study Arms (2)

HEARTS Integrated Hypertension-Diabetes Care

EXPERIMENTAL

Health Centers in the experimental arm receive a package of five multilevel HEARTS implementation strategies adapted to Guatemala for integrated hypertension-diabetes multimorbidity care: (1) training and supportive supervision for health workers; (2) simplifying treatment protocols for hypertension and diabetes; (3) strengthening supply chains of a core set of medications and supplies; (4) task sharing with non-physician health workers; and (5) implementing quality monitoring systems. The implementation period is 30 months, followed by a 12-month maintenance period.

Other: HEARTS implementation strategies; Other: Supply chain strengthening

Enhanced Usual Care

ACTIVE COMPARATOR

Health Centers in the comparator arm receive enhanced usual care consisting of standard clinical care and medications for hypertension and diabetes available through the Ministry of Health system, aligned with national clinical guidelines. As an enhancement to usual care, comparator Health Centers also receive the strategy to strengthen supply chains of medications and supplies. This enhancement ensures that between-arm differences are not due to variations in clinical resource availability and minimizes the risk of contamination, as supply chain management in the MOH system occurs at multiple levels.

Other: Supply chain strengthening

Interventions

Supply chain strengthening OTHER

Strengthening supply chains of a core set of medications and supplies for hypertension and diabetes care. This strategy is provided to both arms to ensure that observed between-arm differences are attributable to the other HEARTS implementation strategies rather than to variations in medication and supply availability.

Enhanced Usual Care; HEARTS Integrated Hypertension-Diabetes Care

HEARTS implementation strategies OTHER

A package of five multilevel implementation strategies based on the WHO/PAHO Hearts Technical Package, adapted to Guatemala: (1) Training and supportive supervision for health workers on evidence-based hypertension and diabetes treatment protocols; (2) Simplifying treatment protocols; (3) Strengthening supply chains of a core set of medications and supplies; (4) Task sharing with non-physician health workers; (5) Implementing quality monitoring systems using standardized registries and indicators.

HEARTS Integrated Hypertension-Diabetes Care

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Systolic blood pressure ≥130 mmHg on ≥2 occasions, defined as the mean of 6 measurements at 2 study visits scheduled at least 1 day apart but within 7 days
• Hemoglobin A1c ≥6.5%
• Able and willing to provide informed consent

You may not qualify if:

• Does not live in Health Center's catchment area or is unwilling to receive care at the Health Center
• Currently pregnant or planning pregnancy in the next 2 years
• Has been diagnosed with type 1 diabetes, or there is high suspicion of this diagnosis by study physicians
• Has severe chronic or terminal illness such that primary care management of hypertension and/or diabetes would be clinically inappropriate, including end-stage kidney disease
• Confined to bed
• Planning to leave the study area in the next 2 years
• Unwilling to comply with protocol requirements

Sponsors & Collaborators

• University of Michigan: lead

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

David Flood, MD

CONTACT

734-647-2892; dcflood@umich.edu

Study Design

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

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made accessible no later than the time of publication of the primary results or the end of the grant period, whichever comes first. Data will be available for a minimum of 10 years.
• Access Criteria: Controlled access through the NHLBI BioLINCC platform. Researchers must submit a data access request and sign a Data Use Agreement. Access and reuse will comply with NIH, institutional, and Guatemalan policies on data sharing and ethical guidelines.