Health TrialsbyHealthPanel

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

ConditionsHypertension (HTN)Type 2 Diabetes
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HEARTS implementation strategies

    Other intervention

    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 intervention

    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.

Treatment groups

1,440 Participants
are divided into 2 treatment groups
Group A: HEARTS Integrated Hypertension-Diabetes CareExperimental treatment 2 interventions
Group B: Enhanced Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in systolic blood pressure

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

Time frame
Enrollment to 12 months
2

Change in hemoglobin A1c

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

Time frame
Enrollment to 12 months

Secondary outcomes

1

Change in diastolic blood pressure

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

Time frame
Enrollment to 12 months
2

Proportion with blood pressure control

Between-arm difference in proportion achieving blood pressure \<130/\<80 mmHg

Time frame
Enrollment to 12 months
3

Proportion with hemoglobin A1c control

Between-arm difference in proportion achieving HbA1c \<7.0%

Time frame
12 months
4

Proportion with combined blood pressure and hemoglobin A1c control

Between-arm difference in proportion achieving blood pressure \<130/\<80 mmHg and HbA1c \<7.0%

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: