Implementing HEARTS in Guatemala

Sponsor
University of Michigan
Study ID
NCT06080451
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Integrated Diabetes and Hypertension Primary Care Model — OTHER
    The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. 1. Training health workers on diabetes and hypertension treatment protocols 2. Team-based care and task sharing 3. Strengthening access to medications and diagnostics 4. Electronic medical record system and registry 5. Systems monitoring and feedback of key indicators
  • Integrated Diabetes and Hypertension Primary Care Model - Providers — OTHER
    The intervention consists of five components that align with the World Health Organization Technical Package for Cardiovascular Disease Management in primary Health Care. 1. Training health workers on diabetes and hypertension treatment protocols 2. Team-based care and task sharing 3. Strengthening access to medications and diagnostics 4. Electronic medical record system and registry 5. Systems monitoring and feedback of key indicators Health care providers will administer this intervention to patient participants and will report on their experience.

Study Details

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.

Key Dates

Start date
Oct 3, 2023
Status verified
Jun 2025
Primary completion
May 27, 2024
Completion
May 27, 2024

Study Design

Enrollment
964 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HEARTS implementation - Patients
    A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the patients whose health markers will be monitored through the study.
  • Experimental: HEARTS implementation - Providers
    A trial for 6 months will be carried out in 11 Ministry of Health primary care facilities starting in October 2023. This arm consists of the health care providers who will be administering care to the patient participants.

Primary Outcome Measure

Score on Feasibility of Intervention Measure (FIM) Questionnaire [ Time Frame: 6 months ]

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