Multicomponent Intervention to Improve Hypertension Control in Central America
Condition: Arterial Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators propose to assess the needs, barriers, and knowledge gaps of hypertension
      control programs in the national health care systems of the Central America 4 region LMIC
      (CA-4: Guatemala, Honduras, El Salvador, and Nicaragua); to conduct a cluster randomized
      trial to test the effect of a multilevel and multicomponent intervention program leveraging
      an existing subnational primary healthcare system in Guatemala, on blood pressure (BP)
      control among hypertensive patients; and to evaluate the adaptability, feasibility, fidelity,
      and sustainability of implementing the program in the primary health care systems of the CA-4
      region. The comprehensive intervention, which includes protocol-based treatment using a
      standard BP management algorithm, team-based collaborative care, BP audit and feedback, home
      BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle
      modification, will last for 18 months. This implementation research study presents high
      public health impact because it will generate urgently needed data on effective, practical,
      and sustainable intervention strategies aimed at reducing BP related disease burden in
      Central America and other low- and middle-income countries.
    

Detailed description: 
      Despite advances in hypertension prevention and treatment research, its prevalence is high
      and increasing, while the proportions of hypertensive patients who are aware, treated, and
      controlled are low, especially in low- and middle-income countries (LMIC). The investigators
      propose to: assess the needs, barriers, and knowledge gaps of hypertension control programs
      in the national health care systems of the Central America 4 region LMIC (CA-4: Guatemala,
      Honduras, El Salvador, and Nicaragua); conduct a cluster randomized trial to test the effect
      of a multilevel and multicomponent intervention program on blood pressure (BP) control among
      Guatemalan hypertensive patients; and evaluate the adaptability, feasibility, fidelity, and
      sustainability of implementing the program in the primary health care systems of the CA-4
      region. The investigators will conduct formative research to assess the needs of system-wide
      intervention programs, barriers and facilitators of BP control strategies, and knowledge gaps
      about implementation for improving hypertension control in the CA-4 health care systems. The
      proposed trial will recruit 1,770 study participants from 32 primary care districts (55
      patients aged ≥22 years with uncontrolled hypertension/district) within a subnational primary
      care network managed by the Guatemalan Ministry of Health. Sixteen health districts will be
      assigned to an 18-month multicomponent intervention, which includes protocol-based treatment
      using: a standard blood pressure (BP) management algorithm, team-based collaborative care, BP
      audit and feedback, home BP monitoring, and health coaching on antihypertensive medication
      adherence and lifestyle modification, and 16 to usual care. BP and other indicators will be
      measured at baseline and at months 6, 12, and 18. The primary clinical outcome is the
      difference in the proportion of patients with controlled BP (<140/90 mmHg) between the
      intervention and control groups at 18 months. The secondary outcome is net change in systolic
      and diastolic BP from baseline to 18 months. Fidelity of the intervention measured monthly by
      intensification of treatment by provider-teams (titration or addition of new medications) and
      adherence to medications in patients will be the primary implementation outcome. Other
      implementation outcomes will be measured every 6 months. The RE-AIM framework will guide the
      development, implementation, and assessment of the intervention, which will translate and
      adapt the Hypertension Control Program in Argentina that has been proven effective and
      feasible. This project have assembled a multidisciplinary investigative team, which will
      collaborate with the public primary care network in Guatemala to conduct this implementation
      research project. The intervention and study outcomes are patient-centered, and patients, MOH
      provider-teams, and other stakeholders will be engaged at every step of the proposed study.
      The investigators will disseminate the study findings and promote scale-up of the proven
      effective intervention program, which will generate urgently needed data on effective,
      adoptable, and sustainable intervention strategies aimed at reducing BP-related disease
      burden in CA-4 and other low-income settings.
    

Intervention name(s): Multicomponent intervention
Intervention type(s): Other
Intervention description(s): An 18-month multicomponent intervention, which includes protocol-based treatment using: a standard blood pressure (BP) management algorithm, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A cluster randomized trial including 32 rural health districts managed by the Ministry of Health (MOH) of Guatemala. Sixteen health districts will be assigned to a multicomponent intervention and 16 to usual care. Each health district will recruit 55 patients aged ≥40 years with uncontrolled hypertension.
Masking: None (Open Label)
Primary purpose: Treatment