NCT03504124

Multicomponent Intervention to Improve Hypertension Control in Central America

Completed Phase 3 Last updated 29 July 2022

What this trial tests

Phase 3 trial testing Multicomponent intervention in Arterial Hypertension in 1,854 participants. Completed in 23 April 2022.

Timeline

17 July 2019

Primary endpoint
23 April 2022

23 April 2022

Quick facts

Lead sponsor	Institute of Nutrition of Central America and Panama
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,854
Start date	17 July 2019
Primary completion	23 April 2022
Estimated completion	23 April 2022
Sites	1 location across Guatemala

Drugs / interventions tested

• Multicomponent intervention

Conditions studied

• Arterial Hypertension — all drugs for Arterial Hypertension →

Sponsor

Institute of Nutrition of Central America and Panama

Who can join

Adults 18 to 90, any sex, with Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial.
   Paniagua-Avila A, Fort MP, Glasgow RE, Gulayin P, et al · · 2020 · cited 22× · PMID 32517806 · DOI 10.1186/s13063-020-04345-8
2. 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.
   Paniagua-Avila A, Shelton RC, Figueroa JC, Guzman AL, et al · · 2024 · cited 9× · PMID 38491376 · DOI 10.1186/s43058-024-00560-5
3. Monitoring Study Participants and Implementation with Phone Calls to Support Hypertension Control During the COVID-19 Pandemic: The Case of a Multicomponent Intervention Trial in Guatemala.
   Hernández-Galdamez D, Mansilla K, Peralta AL, Rodríguez-Szaszdi J, et al · · 2021 · cited 9× · PMID 34900568 · DOI 10.5334/gh.954
4. 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
   Paniagua-Avila A, Shelton RC, Guzman AL, Gutierrez L, et al · · 2023 · DOI 10.21203/rs.3.rs-2362741/v1