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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HEARTS implementation strategies
  • Supply chain strengthening

Treatment groups

1,440 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Michigan

Lead sponsor