Scale up of implementation of a multidimensional intervention to enhance hypertension and diabetes care at the primary care setting: A protocol for a cluster-randomized study in Brazil

Fonseca, Sueli Ferreira, Ribeiro, Antonio Luiz Pinho, Cimini, Christiane Correa Rodrigues, Soares, Thiago Barbabela de Castro, Delfino-Pereira, Polianna, Nogueira, Lucas Tavares, Moura, Regina Marcia Faria, Motta-Santos, Daisy, Ribeiro, Leonardo Bonisson, Camargos, Márcia Cristiane Souza, Paixão, Maria Cristina, Pires, Magda Carvalho, Batchelor, James and Marcolino, Milena Soriano (2023) Scale up of implementation of a multidimensional intervention to enhance hypertension and diabetes care at the primary care setting: A protocol for a cluster-randomized study in Brazil. American Heart Journal, 262, 119-130. (doi:10.1016/j.ahj.2023.04.006).

Abstract

Background: Hypertension and diabetes mellitus (DM) are highly prevalent in low and middle-income countries (LMICs), and the proportion of patients with uncontrolled diseases is higher than in high-income countries. Innovative strategies are required to surpass barriers of low sources, distance and quality of health care. Our aim is to assess the uptake and effectiveness of the implementation of an integrated multidimensional strategy in the primary care setting, for the management of people with hypertension and diabetes mellitus in Brazil.

Methods: This scale up implementation study called Control of Hypertension and diAbetes in MINas Gerais (CHArMING) Project has mixed-methods, and comprehends 4 steps: (1) needs assessment, including a standardized structured questionnaire and focus groups with health care practitioners; (2) baseline period, 3 months before the implementation of the intervention; (3) cluster randomized controlled trial (RCT) with a 12-months follow-up period; and (4) a qualitative study after the end of follow-up. The cluster RCT will randomize 35 centers to intervention (n = 18) or usual care (n = 17). Patients ≥18 years old, with diagnosis of hypertension and/or DM, of 5 Brazilian cities in a resource-constrained area will be enrolled. The intervention consists of a multifaceted strategy, with a multidisciplinary approach, including telehealth tools (decision support systems, short message service, telediagnosis), continued education with an approach to issues related to the care of people with hypertension and diabetes in primary care, including pharmacological and non-pharmacological treatment and behavioral change. The project has actions focused on professionals and patients.

Conclusions: This study consists of a multidimensional strategy with multidisciplinary approach using digital health to improve the control of hypertension and/or DM in the primary health care setting. We expect to provide the basis for implementing an innovative management program for hypertension and DM in Brazil, aiming to reduce the present and future burden of these diseases in Brazil and other LMICs.

Clinical Trial Identifier: This study was registered in ClinicalTrials.gov. (NCT05660928).

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Contributors

Author: James Batchelor

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