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Multicomponent Intervention to Improve Hypertension Control in Central America

NCT03504124 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1854

Last updated 2022-07-29

No results posted yet for this study

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.

Conditions

  • Arterial Hypertension

Interventions

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.

Sponsors & Collaborators

  • Tulane University School of Public Health and Tropical Medicine

    collaborator OTHER

  • Institute for Clinical Effectiveness and Health Policy

    collaborator OTHER

  • Colorado School of Public Health

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Institute of Nutrition of Central America and Panama

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2022-04-23
Completion
2022-04-23

Countries

  • Guatemala

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504124 on ClinicalTrials.gov