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Multicomponent Intervention to Improve Hypertension Control in Central America

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ClinicalTrials.gov Identifier: NCT03504124
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Tulane University School of Public Health and Tropical Medicine
Institute for Clinical Effectiveness and Health Policy
Colorado School of Public Health
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Manuel Ramirez-Zea, Institute of Nutrition of Central America and Panama

Brief 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.

Condition or disease Intervention/treatment Phase
Arterial Hypertension Other: Multicomponent intervention Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1770 participants
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
Official Title: Implementing a Multicomponent Intervention to Improve Hypertension Control in Central America
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Patients will receive a multicomponent intervention.
Other: Multicomponent intervention
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.

No Intervention: Control group
Patients will receive the usual care.



Primary Outcome Measures :
  1. Proportion of controlled blood pressure [ Time Frame: 18 months ]
    Difference in the proportion of patients with controlled blood pressure (<140/90 mmHg) between the intervention and control groups


Secondary Outcome Measures :
  1. Change in systolic blood pressure [ Time Frame: 18 months ]
    Net change in systolic blood pressure from baseline to 18 months

  2. Change in diastolic blood pressure [ Time Frame: 18 months ]
    Net change in diastolic blood pressure from baseline to 18 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients aged ≥40 years with BP >140/90 mmHg at the time of enrollment
  • Patients who receive care at government health facilities

Exclusion Criteria:

  • Pregnant women

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Responsible Party: Manuel Ramirez-Zea, Head, INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama
ClinicalTrials.gov Identifier: NCT03504124     History of Changes
Other Study ID Numbers: 1U01HL138647-01 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases