Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation
Starting soon · Not applicable
Conditions studied: Hypertension (HTN), Type 2 Diabetes
In brief
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 facts
- Study ID
- NCT07536919
- Run by
- University of Michigan
- People needed
- 1440
- Starts
- 2027-05-01
- Expected to finish
- 2030-05-01
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Full record on ClinicalTrials.gov
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