CHArMING - Control of Hypertension and diAbetes in MINas Gerais

In Brazil, the frequency of adults with high blood pressure is around 35%, while diabetes is self-reported in 6.2%. Getting treatment for hypertension and diabetes can avoid people having difficulty managing their illness and their problems getting worse. Limited access to health services and few health workers to support have led to deficiencies in treatment, outcomes and quality of life of hypertensive and diabetic patients. In Minas Gerais state, the university and hospital established a Telehealth Network, in 2005, to use digital health solutions to improve access and quality to health care. A specific intervention in hypertension and diabetes was developed with positive results in the HealthRise project (2016-2018), in the Northeast of Minas Gerais, a remote region with limited number of health resources. The present project will develop a framework to implement this intervention in a larger number of primary health care (PHC) units, using these locations to improve the management of patients with high blood pressure and diabetes.

Training and clinical support developed by UFMG allow health workers in different roles to use the software and clinical workflows during a patient's visit to the PHC. The staff receives guidance and support from the software and additional specialist medical input to help managing hypertension and diabetes using the "best practice". Additionally the software contacts the patient via SMS to check in on the patient regularly, to help remind them about medication, activities and lifestyle changes such as diet that would help them manage and control their disease, empowering them in self-care when away from the care teams. The health care workers also participate in further online and face to face training to help continually develop understanding of the management of these patients.

In the fist part of the project, over the first two years, the teams from the different organisations will work with clinical staff, researchers, software designers, and trainers, to look and improve the intervention and software tools as they are currently being used. In the second part of the project, in years three to five, the teams will undertake a study in the Mucury Valley to compare the use of the intervention and training across the 34 primary health centres: one half of the sites will be given the software and training to treat and manage their patients, and the other half the sites will continue to treat and manage patients in the standard way.
This will be a significant step to evaluate this innovation that has been developed within Brazil and look at how best to support this approach at scale to the wider state or country, reaching many communities living in poor urban and rural settings and reducing the burden of these diseases in this continental country.

In Brazil, the prevalence of hypertension is near 35%, while diabetes is self-reported in 6.2% of adults. Treatment of hypertension and diabetes can avoid complications and death, but, in Brazil and most low- and middle-income countries, blood pressure and glycohemoglobin control rates are still low. The aim of the study is to develop and implement an integrated multidimensional strategy using digital health to be widely used in the PHC setting for the management of patients with hypertension and diabetes, leading to better adherence to glycohemoglobin and blood pressure measurement and decreased glycohemoglobin and blood pressure levels.
The intervention consists of a multidimensional strategy with multidisciplinary approach, including: (a) telehealth tools: teleconsultations, telediagnosis and short message service (SMS); (b) a web system for health professionals including a decision support system; (c) continued education, including web courses and in-person activities; (d) group activities for health professionals, as Balint groups; and (e) educational and groups for hypertensive and diabetic patients.
This study is a partnership among the University of Southampton, Brazilian Federal Universities of Minas Gerais and of Vales do Jequitinhonha e Mucuri and Einstein Hospital.
The study will be conducted in the Mucury Valley, in the northeast region of the Minas Gerais state. The 1st phase will consist in a before-and after study, combined with a qualitative study. The 2nd phase is a cluster randomized controlled open label trial in which 34 PHC units will be randomized to receive or not the intervention. We will recruit hypertensive and diabetic patients from 30 to 80 years-old, 150 per centre, with an expected total sample of 5264 persons.
The overall goal of our application is to build a sustainable model for diabetes and hypertension management, embedded in the Brazilian public health system, aiming to reduce the present and future burden in the country.

A. Potential Benefits of the Proposed Research to the Subjects and Others: Hypertension and diabetes are related to significant morbidity and risk of death. Thus, we propose multidimensional intervention linked to evidence-based care, embedded in the public health system, that aims to provide better management to reduce the burden of the disease individually and in the local community. Moreover, individuals may be diagnosed with other conditions, such as atrial fibrillation, other heart rhythm disturbances, heart failure, etc, and receive treatment that are effective in reducing death and disability, and that they would not receive otherwise. The general Brazilian population may benefit from this proposal, as we will test a model for NCD and management that could be incorporated in other settings in Brazil or abroad to help confronting the growing NCD burden in LMIC. The present application represents a pilot research to implementation that can be extrapolated to other NCDs.

B. Innovative aspects of the project
a. Information technology (IT): Our application includes the use of telehealth and mHealth tools and applications to solve the problem of chronic disease associated with significant morbidity and mortality. IT is one of the disruptive innovations in health care, although there are concerns about the applicability of IT solutions in LMIC. Resource-poor communities are often excluded from innovative technological solutions. We propose to use IT to provide universal and equitable health care to a deprived population, in a remote and poor region, with limited resources.

b. Low cost, sustainability, and scalability: The strategy we intend to implement and evaluate in this proposal uses the available resources, including, PHC centers, and health care personnel already working in the field. If successful, the benefit is sustainable beyond the project period, and will be extended to the whole state, country, and potentially other LMIC.

c. Integration: Most research in hypertension and diabetes refers to screening and treatment as isolated problems; often approaches are not integrated into the health care system. Our proposal is to implement and evaluate a combined strategy to treat hypertension and diabetes patients, integrated to the public health system.

d. Patient empowerment: Our strategy includes involving patients in research using qualitative research methods to gather information that will be used to improve patient participation in health care. Information for patients will be available in low grade level language in hard-copies, website, text messaging, and short videos made by patients for patients.

e. Local health professionals strengthening: We will use innovative approaches to train and support local professionals, such as long-distance learning and qualitative research methods (focus groups), aiming to improve their autonomy to solve problems.
The overall goal of our application is to build a sustainable model for diabetes and hypertension management, embedded in the Brazilian public health system. Data from the present proposal will enable us to construct a resource-effective strategy, focusing in groups of individuals who will mostly benefit from it. The strengths of our application include our well-established telehealth network, use of novel technology tools, support of local health authorities, and potential for research capacity building. Our international collaborative and multi-disciplinary team has investigators of different career levels, and members that are working in the research field, enhancing the feasibility of our proposal. Considering our track record of turning research innovation into public health services, we expect that the present project will provide the basis for implementing an innovative management program for diabetes and hypertension in Brazil, aiming to reduce the present and future burden in the country