Multicomponent Intervention to Improve Hypertension Control in Central America

NCT03504124 | Completed Phase 3 DMC

• 1 other identifier: 1U01HL138647-01
• Study Type: interventional
• Target: 1,854
• Locations: 1 country
• Sites: 1

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.

Conditions

Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Proportion of controlled blood pressure

  Difference in the proportion of patients with controlled blood pressure (\<140/90 mmHg) between the intervention and control groups

  18 months

Secondary Outcomes (2)

• Change in systolic blood pressure

  18 months

• Change in diastolic blood pressure

  18 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients will receive a multicomponent intervention.

Other: Multicomponent intervention

Control group

NO INTERVENTION

Patients will receive the usual care.

Interventions

Multicomponent intervention OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• Institute of Nutrition of Central America and Panama: lead
• Tulane University School of Public Health and Tropical Medicine: collaborator
• Institute for Clinical Effectiveness and Health Policy: collaborator
• Colorado School of Public Health: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Insitute of Nutrition of Central America and Panama

Guatemala City, 01011, Guatemala

Location

Related Publications (3)

• Paniagua-Avila A, Shelton RC, Figueroa JC, Guzman AL, Gutierrez L, Hernandez-Galdamez DR, Ramirez JM, Rodriguez J, Irazola V, Ramirez-Zea M, Fort MP. Assessing the implementation of a multi-component hypertension program in a Guatemalan under-resourced dynamic context: an application of the RE-AIM/PRISM extension for sustainability and health equity. Implement Sci Commun. 2024 Mar 15;5(1):23. doi: 10.1186/s43058-024-00560-5.

  PMID: 38491376 DERIVED

• Paniagua-Avila A, Shelton RC, Guzman AL, Gutierrez L, Galdamez DH, Ramirez JM, Rodriguez J, Irazola V, Ramirez-Zea M, Fort MP. Assessing the implementation of a multi-component hypertension program in a Guatemalan under-resourced dynamic context: An application of the RE-AIM/PRISM extension for sustainability and health equity. Res Sq [Preprint]. 2023 Jan 17:rs.3.rs-2362741. doi: 10.21203/rs.3.rs-2362741/v1.

  PMID: 36712105 DERIVED

• Paniagua-Avila A, Fort MP, Glasgow RE, Gulayin P, Hernandez-Galdamez D, Mansilla K, Palacios E, Peralta AL, Roche D, Rubinstein A, He J, Ramirez-Zea M, Irazola V. Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial. Trials. 2020 Jun 9;21(1):509. doi: 10.1186/s13063-020-04345-8.

  PMID: 32517806 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, INCAP Research Center for the Prevention of Chronic Diseases

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: July 17, 2019
• Primary Completion: April 23, 2022
• Study Completion: April 23, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

GU (1)