Elsevier

American Heart Journal

Volume 262, August 2023, Pages 119-130
American Heart Journal

Trial Designs
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

https://doi.org/10.1016/j.ahj.2023.04.006Get rights and content

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)

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.

References (69)

  • DM Rabi et al.

    Hypertension Canada's 2020 comprehensive guidelines for the prevention, diagnosis, risk assessment, and treatment of hypertension in adults and children

    Can J Cardiol

    (2020)
  • NCD Countdown 2030: worldwide trends in non-communicable disease mortality and progress towards Sustainable Development Goal target 3.4

    Lancet

    (2018)
  • GMM de Oliveira et al.

    Estatística cardiovascular – Brasil 2021

    Arq Bras Cardiol

    (2022)
  • F Marinho et al.

    Burden of disease in Brazil, 1990–2016: a systematic subnational analysis for the global burden of disease study 2016

    Lancet

    (2018)
  • ALP Ribeiro et al.

    Cardiovascular health in Brazil: trends and perspectives

    Circulation

    (2016)
  • RV Picon et al.

    Hypertension management in Brazil: usual practice in primary care-a meta-analysis

    Int J Hypertens

    (2017)
  • LV Viana et al.

    Poor glycaemic control in Brazilian patients with type 2 diabetes attending the public healthcare system: a cross-sectional study

    BMJ Open

    (2013)
  • RM Carey et al.

    Treatment of hypertension: a review

    JAMA

    (2022)
  • Introduction: standards of medical care in diabetes-2022

    Diabetes Care

    (2022)
  • Y Mao et al.

    Impact and efficacy of mobile health intervention in the management of diabetes and hypertension: a systematic review and meta-analysis

    BMJ Open Diabetes Res Care

    (2020)
  • Y Wang et al.

    Effectiveness of mobile health interventions on diabetes and obesity treatment and management: systematic review of systematic reviews

    JMIR Mhealth Uhealth

    (2020)
  • RT Sutton et al.

    An overview of clinical decision support systems: benefits, risks, and strategies for success

    NPJ Digit Med

    (2020)
  • S Van de Velde et al.

    A systematic review of trials evaluating success factors of interventions with computerised clinical decision support

    Implement Sci

    (2018)
  • WA Odendaal et al.

    Health workers’ perceptions and experiences of using mHealth technologies to deliver primary healthcare services: a qualitative evidence synthesis

    Cochrane Database Syst Rev

    (2020)
  • D Golinelli et al.

    Adoption of digital technologies in health care during the COVID-19 pandemic: systematic review of early scientific literature

    J Med Internet Res

    (2020)
  • LS Flor et al.

    Community-based interventions for detection and management of diabetes and hypertension in underserved communities: a mixed-methods evaluation in Brazil, India, South Africa and the USA

    BMJ Global Health

    (2020)
  • MS Marcolino et al.

    development and implementation of a decision support system to improve control of hypertension and diabetes in a resource-constrained area in Brazil: mixed methods study

    J Med Internet Res

    (2021)
  • KF Schulz et al.

    CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials

    BMJ

    (2010)
  • MK Campbell et al.

    Consort 2010 statement: extension to cluster randomised trials

    BMJ

    (2012)
  • RE Glasgow et al.

    Evaluating the public health impact of health promotion interventions: the RE-AIM framework

    Am J Public Health

    (1999)
  • S Wiltsey Stirman et al.

    The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions

    Implement Sci

    (2019)
  • Krueger RA, Casey MA. Focus groups: a practical guide for applied research....
  • CM Dall'agnol et al.

    A noção de tarefa nos grupos focais

    Rev Gaúcha Enferm

    (2012)
  • TE Schönholzer et al.

    Implementation of the e-SUS primary care system: impact on the routine of primary health care professionals

    Rev Latino-Am Enfermagem

    (2021)
  • CA. Tuttas

    Lessons learned using Web conference technology for online focus group interviews

    Qual Health Res

    (2015)
  • RW Bohannon et al.

    Two-minute step test of exercise capacity: systematic review of procedures, performance, and clinimetric properties

    J Geriatr Phys Ther

    (2019)
  • Brasil. Ministério da Saúde. SISVAN - Sistema de Vigilância Alimentar e Nutricional. Marcador de Consumo...
  • NM Ivers et al.

    Allocation techniques for balance at baseline in cluster randomized trials: a methodological review

    Trials

    (2012)
  • Brasil. Ministério da Saúde. Política nacional de atenção básica. Portaria n°...
  • Brasil. Ministério da Saúde. Cria os núcleos de apoio à saúde da família - NASF. Portaria n°...
  • CMC Alonso do et al.

    Work of community health agents in the Family Health Strategy: meta-synthesis

    Rev Saúde Pública

    (2018)
  • Brasil. Instituto Brasileiro de Geografia e Estatística. Estimativas da população residente no brasil e unidades da...
  • Brasil. Governo do Estado de Minas Gerais. Secretaria de Estado de Saúde de Minas Gerais. Plano Diretor de...
  • Brasil. Instituto Brasileiro de Geografia e Estatística. Índice de Desenvolvimento Humano. IDH-IBGE Cidades....
  • Cited by (0)

    View full text