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

Sponsor
University of Michigan
Study ID
NCT07536919
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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).

Key Dates

First listed
Apr 17, 2026
Start date
May 1, 2027
Status verified
Apr 2026
Primary completion
May 1, 2030
Completion
May 1, 2030

Study Design

Enrollment
1,440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HEARTS Integrated Hypertension-Diabetes Care
    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.
  • Active Comparator: Enhanced Usual Care
    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.

Primary Outcome Measure

Change in systolic blood pressure [ Time Frame: Enrollment to 12 months ]

Central Contacts

Find similar trials

Nationwide
Type 2 diabetes trialsEndocrinology trialsMetabolic health trialsWeight loss trials

Related Studies