NCT07536919Not yet recruiting
Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation
Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation (MULTI-HEARTS)
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1440 (estimated)
- First submitted
- 12 Apr 2026
- Start date
- 1 May 2027
- Primary completion date
- 1 May 2030
- Lead sponsor
- University of Michigan
- Diseases
- High blood pressure, Type 2 diabetes
- NCT number
- NCT07536919
What you commit to
- Study type: Interventional
- Planned participants: 1440
- From 1 May 2027 to the primary completion date, 1 May 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
- Confined to bed
- Planning to leave the study area in the next 2 years
- Unwilling to comply with protocol requirements
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.