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Open Access 01-12-2020 | Care | Study protocol

Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial

Authors: Alejandra Paniagua-Avila, Meredith P. Fort, Russell E. Glasgow, Pablo Gulayin, Diego Hernández-Galdamez, Kristyne Mansilla, Eduardo Palacios, Ana Lucia Peralta, Dina Roche, Adolfo Rubinstein, Jiang He, Manuel Ramirez-Zea, Vilma Irazola

Published in: Trials | Issue 1/2020

Abstract

Background

Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback.

Methods

Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness.

Discussion

We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs.

Trial registration

ClinicalTrials.gov: NCT03504124. Registered on 20 April 2018.

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Title: Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial
Authors: Alejandra Paniagua-Avila
Meredith P. Fort
Russell E. Glasgow
Pablo Gulayin
Diego Hernández-Galdamez
Kristyne Mansilla
Eduardo Palacios
Ana Lucia Peralta
Dina Roche
Adolfo Rubinstein
Jiang He
Manuel Ramirez-Zea
Vilma Irazola
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Care
Hypertension
Climate Change
Hypertension
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04345-8

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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