Trial DesignsScale 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
Section snippets
Background
Noncommunicable diseases (NCDs) are a major global health challenge, mainly in low- and middle-income countries (LMICs).1 In Brazil, NCDs account for over 72% of all premature deaths, of which 30% were due to cardiovascular diseases (CVD).2 Hypertension and diabetes mellitus (DM) are leading modifiable risk factors for CVD. Population aging and the increase in the prevalence of these risk factors, in addition to high rates of uncontrolled blood pressure and glucose levels, are important causes
Methods
This CHArMING Project is a scale-up implementation study. Methods were designed and reported in accordance with the CONSORT statement and its extension regarding cluster RCTs17,18 (Supplementary Material 1).
Discussion
This study aims to implement and evaluate an integrated multidimensional strategy using digital health for improving the control of hypertension and/or DM in the primary health care center in low-income regions. The results will demonstrate the impact of the intervention, indicating an important public health strategy with the possibility of expansion to other territories.
Despite the current “hype” around digital health, there is a huge gap between proposed solutions, tested in pilot or
Conclusions
CHArMING Project is a scale-up implementation study that will investigate the effects of a multidimensional intervention using digital health tools in the primary health care setting to improve hypertension and DM control in low-income regions of Brazil. If successful, the trial will provide the basis for a sustainable model of hypertension and DM management integrated into the health care system for large-scale adoption in Brazil and other LMICs.
Ethics Approval and Consent to Participate
The Brazilian National Commission for Research Ethics (CAAE 55598822.0.0000.5149) approved the execution of this study. Informed consent was obtained from all participants.
Funding
This study is supported by the United Kingdom Medical Research Council [grant number MR/T02528X/1], as part of a Global Alliance of Chronic Diseases fifth call of applications(SU17), Minas Gerais State Agency for Research and Development (Fundação de Amparo à Pesquisa do Estado de Minas Gerais - FAPEMIG) [grant number PPM-00428-17 and RED-00081-16], and CAPES Foundation (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior) [Grant Number 88887.507149/2020-00]. ALPR was supported in part
Consent for publication
Not applicable.
Availability of data and materials
Not applicable.
CRediT authorship contribution statement
Sueli Ferreira Fonseca: Conceptualization, Methodology, Writing – original draft, Writing – review & editing. Antonio Luiz Pinho Ribeiro: Conceptualization, Methodology, Resources, Writing – review & editing, Supervision, Funding acquisition. Christiane Correa Rodrigues Cimini: Conceptualization, Methodology, Writing – original draft, Writing – review & editing. Thiago Barbabela de Castro Soares: Methodology, Writing – original draft, Writing – review & editing. Polianna Delfino-Pereira:
Conflict of interest
None reported.
Acknowledgments
The authors would like to thank the city hall of each participating cities: Caraí, Carlos Chagas, Malacacheta, Novo Cruzeiro, and Poté. We also thank all the primary care teams, who care for the patients.
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