Clinical trial NCT06080451: Implementing HEARTS in Guatemala
Official title: Implementing Integrated Diabetes and Hypertension Management in Guatemala Using the HEARTS Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Institute of Nutrition of Central America and Panama
name: Ministry of Health of Guatemala
First posted: 2023-10-12
Enrollment: 866
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The HEARTS Technical Package was developed by the World Health Organization to address the implementation gap of cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala.

Detailed description: A single-arm pilot trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in September 2023. A planned sample of 100 adult patients diagnosed with diabetes (n=45), hypertension (n=45), or both (n=10) will be enrolled. The intervention will consist of HEARTS-aligned components: Training health workers on Healthy-lifestyle counseling and Evidence-based treatment protocols; strengthening Access to medications and diagnostics; training on Risk-based cardiovascular disease management; Team-based care and task sharing; and Systems monitoring and feedback, including implementation of a facility-based electronic monitoring tool at the individual level. Co-primary outcomes of feasibility and acceptability will be assessed using an explanatory sequential mixed methods design. Secondary outcomes include clinical effectiveness (treatment with medication, glycemic control, and blood pressure control) and key implementation outcomes (adoption, fidelity, usability, and sustainability).

Eligibility criteria: Patient participants

Inclusion criteria:

* Non-pregnant adults aged ≥18 years
* Diagnoses of type 2 diabetes or hypertension
* Present for routine care at participating MOH primary health facilities

Exclusion criteria:

* Confirmed or suspected type 1 diabetes
* Pregnant
* Are not managed at MOH health centers or health posts

Provider/other participants

Inclusion criteria:

• Participation in delivering HEARTS or on the Technical Advisory Committee

Exclusion criteria:

• None

Primary outcomes:
measure: Score on Feasibility of Intervention Measure (FIM) Questionnaire
timeFrame: 6 months
measure: Number of target health districts that met enrollment goals
timeFrame: 6 months
measure: Score on Acceptability of Intervention Measure (AIM) Questionnaire
timeFrame: 6 months
measure: Proportion of patient participants with subsequent follow-up visit within 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Hypertension treatment rate
timeFrame: 6 months
measure: Diabetes treatment rate
timeFrame: 6 months
measure: Proportion of participants achieving glycemic control
timeFrame: 6 months
measure: Proportion achieving control of blood pressure
timeFrame: 6 months
measure: Mean systolic blood pressure
timeFrame: 6 months
measure: Mean diastolic blood pressure
timeFrame: 6 months
measure: Adoption
timeFrame: 6 months
measure: Fidelity - health worker training
timeFrame: 6 months
measure: Fidelity - chart audit
timeFrame: 6 months
measure: Fidelity - team-based care and task sharing
timeFrame: 6 months
measure: Fidelity - access to medicines and diagnostics
timeFrame: 6 months
measure: Fidelity - facility-based electronic monitoring tool
timeFrame: 6 months
measure: Fidelity - systems monitoring and feedback
timeFrame: 6 months
measure: Usability
timeFrame: 6 months
measure: Sustainability
timeFrame: 6 months
Other outcomes:
Locations:
city: San Pablo
country: Guatemala
facility: Ministry of Health clinics
state: Sololá
Study officials:
affiliation: University of Michigan
name: David Flood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wellmann IA, Ayala LF, Rodriguez JJ, Guetterman TC, Irazola V, Palacios E, Huffman MD, Rohloff P, Heisler M, Ramirez-Zea M, Flood D. Implementing integrated hypertension and diabetes management using the World Health Organization's HEARTS model: protocol for a pilot study in the Guatemalan national primary care system. Implement Sci Commun. 2024 Jan 9;5(1):7. doi: 10.1186/s43058-023-00539-8.