Hyperglycemia is prevalent in critical care, as patients experience stress-induced hyperglycemia, even with no history of diabetes. Hyperglycemia has a significant impact on patient mortality, outcome and health care cost. Tight regulation can significantly reduce these negative outcomes, but achieving it remains clinically elusive, particularly with regard to what constitutes tight control and what protocols are optimal in terms of results and clinical effort. Hyperglycemia in critical care is not largely benign, as once thought, and has a deleterious effect on outcome. Recent studies have shown that tight glucose regulation to average levels from 6.1–7.75 mmol/L can reduce mortality 17–45%, while also significantly reducing other negative clinical outcomes. However, clinical results are highly variable and there is little agreement on what levels of performance can be achieved and how to achieve them. A typical clinical solution is to use ad-hoc protocols based primarily on experience, where large amounts of insulin, up to 50 U/hr, are titrated against glucose measurements variably taken every 1–4 hours. When combined with the unpredictable and sudden metabolic changes that characterise this aspect of critical illness and/or clinical changes in nutritional support, this approach results in highly variable blood glucose levels. The overall result is sustained periods of hyper- or hypo- glycemia, characterised by oscillations between these states, which can adversely affect clinical outcomes and mortality. The situation is exacerbated by exogenous nutritional support regimes with high dextrose content. Model-based predictive control can deliver patient specific and adaptive control, ideal for such a highly dynamic problem. A simple, effective physiological model is presented in this thesis, focusing strongly on clinical control feasibility. This model has three compartments for glucose utilisation, interstitial insulin and its transport, and insulin kinetics in blood plasma. There are two patient specific parameters, the endogenous glucose removal and insulin sensitivity. A novel integral-based parameter identification enables fast and accurate real-time model adaptation to individual patients and patient condition. Three stages of control algorithm developments were trialed clinically in the Christchurch Hospital Department of Intensive Care Medicine. These control protocols are adaptive and patient specific. It is found that glycemic control utilising both insulin and nutrition interventions is most effective. The third stage of protocol development, SPRINT, achieved 61% of patient blood glucose measurements within the 4–6.1 mmol/L desirable glycemic control range in 165 patients. In addition, 89% were within the 4–7.75 mmol/L clinical acceptable range. These values are percentages of the total number of measurements, of which 47% are two-hourly, and the rest are hourly. These results showed unprecedented tight glycemic control in the critical care, but still struggle with patient variability and dynamics. Two stochastic models of insulin sensitivity for the critically ill population are derived and presented in this thesis. These models reveal the highly dynamic variation in insulin sensitivity under critical illness. The stochastic models can deliver probability intervals to support clinical control interventions. Hypoglycemia can thus be further avoided with the probability interval guided intervention assessments. This stochastic approach brings glycemic control to a more knowledge and intelligible level. In “virtual patient” simulation studies, 72% of glycemic levels were within the 4–6.1 mmol/L desirable glycemic control range. The incidence level of hypoglycemia was reduced to practically zero. These results suggest the clinical advances the stochastic model can bring. In addition, the stochastic models reflect the critical patients’ insulin sensitivity driven dynamics. Consequently, the models can create virtual patients to simulated clinical conditions. Thus, protocol developments can be optimised with guaranteed patient safety. Finally, the work presented in this thesis can act as a starting point for many other glycemic control problems in other environments. These areas include the cardiac critical care and neonatal critical care that share the most similarities to the environment studied in this thesis, to general diabetes where the population is growing exponentially world wide. Furthermore, the same pharmacodynamic modelling and control concept can be applied to other human pharmacodynamic control problems. In particular, stochastic modelling can bring added knowledge to these control systems. Eventually, this added knowledge can lead clinical developments from protocol simulations to better clinical decision making.

A asma é uma doença inflamatória crônica das vias aéreas caracterizada por obstrução reversível, inflamação e hiperresponsividade a diversos estímulos. O exercício, seja ele de caráter aeróbio ou respiratório, é muito utilizado no tratamento de pacientes asmáticos, porém, pouco se sabe sobre os benefícios desses exercícios no processo inflamatório e no manejo clínico dessa doença. Objetivo: Comparar o efeito do exercício aeróbio e respiratório no controle clínico, inflamação pulmonar e capacidade funcional de pacientes com asma persistente moderada ou grave. Métodos: Foram estudados 50 adultos asmáticos divididos aleatoriamente em dois grupos: aeróbio (GA; n=28) e respiratório (GR; n=22). O tratamento foi realizado em 2 sessões semanais, durante 3 meses, totalizando 24 sessões com duração de 40 minutos cada uma, sendo que o GA praticou exercício aeróbio em esteira ergométrica e o GR praticou exercícios respiratórios baseados na técnica de Yoga. Ambos os grupos participaram de um programa educacional constituído de 2 aulas antes do início das intervenções. Antes e após as intervenções foram avaliados: o controle clínico (Asthma Control Questionnaire - ACQ, Asthma Control Test - ACT e diário de sintomas), a inflamação pulmonar (celularidade no escarro e fração exalada de óxido nítrico - FeNO), a capacidade funcional (Incremental shuttle walking test) e a função pulmonar (espirometria). Foi utilizado o teste Komolgorov-Smirnov para verificar a normalidade dos dados e a análise de variância (ANOVA) de dois fatores com medidas repetidas, associado ao post hoc de Holm Sidak para comparar as diferenças entre e intra-grupos. Resultados: Houve melhora do controle clínico avaliado pelo ACQ apenas no GA (p < 0,05), assim como a diminuição na porcentagem de eosinófilos no escarro (p < 0,05) e o aumento nos dias livres de sintomas (p < 0,05). Ambos os grupos melhoraram o controle clínico avaliado pelo ACT e a capacidade funcional (p < 0,05). Conclusão: Esses resultados sugerem que ambos os exercícios proporcionam benefícios para pacientes com asma persistente moderada e grave, porém, o exercício aeróbio resultou em mais benefícios clínicos / Asthma is a chronic inflammatory disease of the airway characterized by reversible obstruction, inflammation and hyperresponsiveness of various stimuli. Aerobic or breathing exercise, have been used on treatment of asthmatic patients, however, little is known about the benefits of these exercises in clinical management and inflammatory process of the disease. Objective: To compare the effect of aerobic and breathing exercise in clinical control, airway inflammation and functional capacity of patients with moderate or severe persistent asthma. Methods: 50 asthmatic adults were randomly divided into two groups: aerobic (AG; n = 28) and breathing group (BG, n = 22). The treatment was composed of two weekly sessions, during three months, totaling 24 sessions with duration of 40 minutes each. AG practiced aerobic exercise in a treadmill, while BG practiced breathing exercises based on Yoga technique. Both groups participated of an education program that consists of two classes before the interventions. Before and after the interventions were evaluated: clinical control (Asthma Control Questionnaire - ACQ, Asthma Control Test - ACT, and symptoms diary), airway inflammation (cellularity in sputum and fraction exhaled nitric oxide - FeNO), functional capacity (incremental shuttle walking test) and lung function (spirometry). It was used Komolgorov-Smirnov test to verify the normality of the data and analysis of variance two way with repeated measures (ANOVA), associated to post hoc of Holm Sidak to analize differences between and within groups. Results: There was improvement of clinical control evaluated by ACQ only in AG (p < 0.05), as a decrease in eosinophil percentage in sputum (p < 0.05) and an increase in free days of symptoms (p < 0,05). Both groups improved clinical control evaluated by ACT and functional capacity (p < 0.05). Conclusion: These data suggest that both exercises provide benefits to patients with moderate or severe persistent asthma, however, the aerobic exercise resulted in more clinical benefits

The incidence of Type 1 diabetes is growing yearly. Worryingly, the aetiology of the disease is inconclusive. What is known is that the total number of affected individuals, as well as the severity and number of associated complications are growing for this chronic disease. With increasing complications due to severity, length of exposure, and poor control, the disease is beginning to consume an increasingly major portion of healthcare costs to the extent that it poses major economic risks in several nations. Research has shown that intensive insulin therapy aimed at certain minimum glycosylated haemoglobin threshold levels reduces the incidence of complications by up to 76% compared to conventional insulin therapy. Moreover, the effects of such intensive therapy regimes over a 6.5y duration persists for at least 10y after, a so called metabolic memory. Thus, early intervention can slow the momentum of complications far more easily than later intervention. Early, safe, intensive therapy protocols offer potential solutions to the growing social and economic effects of diabetes. Since the 1970s, the artificial endocrine pancreas has been heralded as just this type of solution. However, no commercial product currently exists, and ongoing limitations in sensors and pumps have resulted in, at best, modest clinical advantages over conventional methods of insulin administration or multiple daily injection. With high upfront costs, high costs of consumables, significant complexity, and the extensive infrastructure and support required, these systems and devices are only used by 2-15% of individuals with Type 1 diabetes. Clearly, there is an urgent need to address the large majority of the Type 1 diabetes population using conventional glucose measurement and insulin administration. For these individuals, current conventional or intensive therapies are failing to deliver recommended levels of glycaemic control. This research develops an understanding of clinical glycaemic control using conventional insulin administration and glucose measurement techniques in Type 1 diabetes based on a clinically validated in silico virtual patient simulation. Based on this understanding, a control protocol for Type 1 diabetes that is relatively simple and clinically practical is developed. The protocol design incorporates physiological modelling and engineering techniques to adapt to individual patient clinical requirements. By doing so, it produces accurate, patient-specific recommendations for insulin interventions. Initially, a simple, physiological compartmental model for the pharmacokinetics of subcutaneously injected insulin is developed. While the absorption process itself is subject to significant potential variability, such models enable a real-time estimation of plasma insulin concentration. This information would otherwise be lacking in the clinical environment of outpatient Type 1 diabetes treatment due to the inconvenience, cost, and laboratory turnaround for plasma insulin measurements. Hence, this validated model offers significant opportunity to optimise therapy selection. An in silico virtual patient simulation tool is also developed. A virtual patient cohort is developed on patient data from a representative cohort of the broad diabetes population. The simulation tool is used to develop a robust, adaptive protocol for prandial insulin dosing against a conventional intensive insulin therapy, as well as a controls group representative of the general diabetes population. The effect on glycaemic control of suboptimal and optimal, prandial and basal insulin therapies is also investigated, with results matching clinical expectations. To gauge the robustness of the developed adaptive protocol, a Monte Carlo analysis is performed, incorporating realistic and physiological errors and variability. Due to the relatively infrequent glucose measurement in outpatient Type 1 diabetes, a method for identifying the diurnal cycle in effective insulin sensitivity and modelling it in retrospective patient data is also presented. The method consists of identifying deterministic and stochastic components in the patient effective insulin sensitivity profile. Circadian rhythmicity and sleep-wake phases have profound effects on effective insulin sensitivity. Identification and prediction of this rhythm is of utmost clinical relevance, with the potential for safer and more effective glycaemic control, with less frequent measurement. It is thus a means of further enhancing any robust protocol and making it more clinically practical to implement. Finally, this research presents an entire framework for the realistic, and rapid development and testing of clinical glycaemic control protocols for outpatient Type 1 diabetes. The models and methods developed within this framework allow rapid and physiological identification of time-variant, patient-specific, effective insulin sensitivity profiles. These profiles form the responses of the virtual patient and can be used to develop and robustly test clinical glycaemic control protocols in a broad range of patients. These effective insulin sensitivity profiles are also rich in dynamics, specifically those circadian in nature which can be identified, and used to provide more accurate glycaemic prediction with the potential for safer and more effective control.

A asma é uma doença inflamatória crônica das vias aéreas caracterizada por obstrução reversível, inflamação e hiperresponsividade a diversos estímulos. O exercício, seja ele de caráter aeróbio ou respiratório, é muito utilizado no tratamento de pacientes asmáticos, porém, pouco se sabe sobre os benefícios desses exercícios no processo inflamatório e no manejo clínico dessa doença. Objetivo: Comparar o efeito do exercício aeróbio e respiratório no controle clínico, inflamação pulmonar e capacidade funcional de pacientes com asma persistente moderada ou grave. Métodos: Foram estudados 50 adultos asmáticos divididos aleatoriamente em dois grupos: aeróbio (GA; n=28) e respiratório (GR; n=22). O tratamento foi realizado em 2 sessões semanais, durante 3 meses, totalizando 24 sessões com duração de 40 minutos cada uma, sendo que o GA praticou exercício aeróbio em esteira ergométrica e o GR praticou exercícios respiratórios baseados na técnica de Yoga. Ambos os grupos participaram de um programa educacional constituído de 2 aulas antes do início das intervenções. Antes e após as intervenções foram avaliados: o controle clínico (Asthma Control Questionnaire - ACQ, Asthma Control Test - ACT e diário de sintomas), a inflamação pulmonar (celularidade no escarro e fração exalada de óxido nítrico - FeNO), a capacidade funcional (Incremental shuttle walking test) e a função pulmonar (espirometria). Foi utilizado o teste Komolgorov-Smirnov para verificar a normalidade dos dados e a análise de variância (ANOVA) de dois fatores com medidas repetidas, associado ao post hoc de Holm Sidak para comparar as diferenças entre e intra-grupos. Resultados: Houve melhora do controle clínico avaliado pelo ACQ apenas no GA (p < 0,05), assim como a diminuição na porcentagem de eosinófilos no escarro (p < 0,05) e o aumento nos dias livres de sintomas (p < 0,05). Ambos os grupos melhoraram o controle clínico avaliado pelo ACT e a capacidade funcional (p < 0,05). Conclusão: Esses resultados sugerem que ambos os exercícios proporcionam benefícios para pacientes com asma persistente moderada e grave, porém, o exercício aeróbio resultou em mais benefícios clínicos / Asthma is a chronic inflammatory disease of the airway characterized by reversible obstruction, inflammation and hyperresponsiveness of various stimuli. Aerobic or breathing exercise, have been used on treatment of asthmatic patients, however, little is known about the benefits of these exercises in clinical management and inflammatory process of the disease. Objective: To compare the effect of aerobic and breathing exercise in clinical control, airway inflammation and functional capacity of patients with moderate or severe persistent asthma. Methods: 50 asthmatic adults were randomly divided into two groups: aerobic (AG; n = 28) and breathing group (BG, n = 22). The treatment was composed of two weekly sessions, during three months, totaling 24 sessions with duration of 40 minutes each. AG practiced aerobic exercise in a treadmill, while BG practiced breathing exercises based on Yoga technique. Both groups participated of an education program that consists of two classes before the interventions. Before and after the interventions were evaluated: clinical control (Asthma Control Questionnaire - ACQ, Asthma Control Test - ACT, and symptoms diary), airway inflammation (cellularity in sputum and fraction exhaled nitric oxide - FeNO), functional capacity (incremental shuttle walking test) and lung function (spirometry). It was used Komolgorov-Smirnov test to verify the normality of the data and analysis of variance two way with repeated measures (ANOVA), associated to post hoc of Holm Sidak to analize differences between and within groups. Results: There was improvement of clinical control evaluated by ACQ only in AG (p < 0.05), as a decrease in eosinophil percentage in sputum (p < 0.05) and an increase in free days of symptoms (p < 0,05). Both groups improved clinical control evaluated by ACT and functional capacity (p < 0.05). Conclusion: These data suggest that both exercises provide benefits to patients with moderate or severe persistent asthma, however, the aerobic exercise resulted in more clinical benefits

A asma é uma doença pulmonar inflamatória crônica com alta prevalência e que leva a importantes danos funcionais à saúde e à qualidade de vida do paciente. A fisiopatologia da asma é caracterizada por intensa imunorregulação e o exercício físico pode ter um papel importante nesta resposta inflamatória devido a seus efeitos imunorreguladores. Objetivo: Avaliar o efeito de um programa de treinamento físico aeróbio na inflamação sistêmica e pulmonar, no controle clinico e fatores de saúde relacionados à qualidade de vida controle clínico de pacientes adultos com asma persistente moderada ou grave. Métodos: Foram estudados 58 adultos asmáticos divididos aleatoriamente nos grupos controle (GC; n=28) e treinado (GT; n=30) e 16 indivíduos não asmáticos (GNA). Os pacientes do GC foram submetidos a um programa educacional e a um programa de exercícios respiratórios, enquanto os pacientes do GT foram submetidos a todos os procedimentos do grupo controle e a um programa de condicionamento físico aeróbio. A resposta imune foi avaliação pelo perfil plasmático das citocinas Th1 (fator de necrose tumoral, interleucina-6 (IL-6), IL-8), Th2 (IL-4, IL- 5), regulatórias (IL-10) e quimiocinas (MCP-1, IP-10, MIG, RANTES) tanto cronicamente como após uma sessão de exercício. Antes e após a intervenção todos os pacientes realizaram uma prova de função pulmonar, um teste cardiopulmonar de esforço, avaliação do controle clínico, dos fatores de saúde relacionados a qualidade de vida (FSRQV), da fração exalada de óxido nítrico (FeNO), exame de escarro induzido e coleta de amostra sanguínea. Os sujeitos do GNA realizaram apenas um teste cardiopulmonar de esforço e a coleta de sangue. Resultados: Os pacientes com asma persistente moderada ou grave submetidos a um programa de condicionamento físico aeróbio apresentaram redução no plasma das interleucinas (IL) 6, IL-8 e proteína quimiotática de monócito-1 (MCP-1) (p < 0,05). Uma única sessão de exercício eleva os níveis de IL-6, IL-8 e IL-5, para depois retornar ao seu valor basal uma hora após o exercício (p < 0,05). A IL-10 também aumentou, porém manteve-se em níveis mais elevados mesmo uma hora após o exercício (p < 0,05). A inflamação pulmonar reduziu apenas nos pacientes do GT com níveis elevados de eosinófilo e FeNO (p < 0,05). Os FSRQV, controle clínico e capacidade física também melhoraram apenas no GT (p < 0,005). Conclusão: Nossos resultados mostram que a melhora da capacidade física de pacientes asmáticos pode ter um efeito anti-inflamatório e que pode ser relevante para o manejo clínico destes pacientes / Asthma is a chronic inflammatory disorder of the airway with high prevalence that leads functional impairment to health related quality of life (HRQoL). The pathophysiology of asthma is characterized by intense immunoregulation and exercise can play an important role in this inflammatory response due to its immunoregulatory effects. Objective: To evaluate the effect of an aerobic training program on systemic and pulmonary inflammation, clinical control and HRQoL of adult patients with moderate or severe persistent asthma. Methods: Fifty-eight asthmatic adult patients were randomly assigned to either control (CG, n = 28) or training groups (TG, n = 30) and 16 subjects non-asthmatic (NAG). The CG performed an educational program and breathing exercises, while the TG performed all procedures in the CG and an aerobic training program. The immune response was assessed by plasma levels of Th1 cytokines (tumor necrosis factor, interleukin-6 (IL-6), IL-8, Th2 (IL-4, IL-5), regulatory (IL-10) and chemokines (MCP-1, IP-10, MIG, RANTES), either chronically and after a single bout of exercise. Before and after the intervention all patients performed a pulmonary function test, cardiopulmonary exercise testing, clinical control test, HRQoL questionnaire, fractional exhaled nitric oxide (FeNO), induced sputum and blood sample. The NAG performed only the cardiopulmonary exercise test and plasma levels of cytokines. Results: Patients that performed a aerobic training program decreased plasma of interleukin (IL) 6, IL-8 and monocyte chemotactic protein-1 (MCP-1) (p < 0.005). A single bout session of exercise raises the levels of IL-6, IL-8 and IL-5, and then return to baseline one hour after exercise (p < 0.05). IL-10 has also increased immediately after exercise and its levels remained higher even for one hour (p < 0.05). The pulmonary inflammation reduced only GT patients with high levels of eosinophils and FeNO (p < 0.05). The FSRQV, clinical control and physical capacity also improved only in GT (p < 0.05). Conclusion: Our results show that the improvement of the physical capacity of patients with asthma may have an anti-inflammatory effect and may be relevant for the clinical management of these patients

A asma é uma doença pulmonar inflamatória crônica com alta prevalência e que leva a importantes danos funcionais à saúde e à qualidade de vida do paciente. A fisiopatologia da asma é caracterizada por intensa imunorregulação e o exercício físico pode ter um papel importante nesta resposta inflamatória devido a seus efeitos imunorreguladores. Objetivo: Avaliar o efeito de um programa de treinamento físico aeróbio na inflamação sistêmica e pulmonar, no controle clinico e fatores de saúde relacionados à qualidade de vida controle clínico de pacientes adultos com asma persistente moderada ou grave. Métodos: Foram estudados 58 adultos asmáticos divididos aleatoriamente nos grupos controle (GC; n=28) e treinado (GT; n=30) e 16 indivíduos não asmáticos (GNA). Os pacientes do GC foram submetidos a um programa educacional e a um programa de exercícios respiratórios, enquanto os pacientes do GT foram submetidos a todos os procedimentos do grupo controle e a um programa de condicionamento físico aeróbio. A resposta imune foi avaliação pelo perfil plasmático das citocinas Th1 (fator de necrose tumoral, interleucina-6 (IL-6), IL-8), Th2 (IL-4, IL- 5), regulatórias (IL-10) e quimiocinas (MCP-1, IP-10, MIG, RANTES) tanto cronicamente como após uma sessão de exercício. Antes e após a intervenção todos os pacientes realizaram uma prova de função pulmonar, um teste cardiopulmonar de esforço, avaliação do controle clínico, dos fatores de saúde relacionados a qualidade de vida (FSRQV), da fração exalada de óxido nítrico (FeNO), exame de escarro induzido e coleta de amostra sanguínea. Os sujeitos do GNA realizaram apenas um teste cardiopulmonar de esforço e a coleta de sangue. Resultados: Os pacientes com asma persistente moderada ou grave submetidos a um programa de condicionamento físico aeróbio apresentaram redução no plasma das interleucinas (IL) 6, IL-8 e proteína quimiotática de monócito-1 (MCP-1) (p < 0,05). Uma única sessão de exercício eleva os níveis de IL-6, IL-8 e IL-5, para depois retornar ao seu valor basal uma hora após o exercício (p < 0,05). A IL-10 também aumentou, porém manteve-se em níveis mais elevados mesmo uma hora após o exercício (p < 0,05). A inflamação pulmonar reduziu apenas nos pacientes do GT com níveis elevados de eosinófilo e FeNO (p < 0,05). Os FSRQV, controle clínico e capacidade física também melhoraram apenas no GT (p < 0,005). Conclusão: Nossos resultados mostram que a melhora da capacidade física de pacientes asmáticos pode ter um efeito anti-inflamatório e que pode ser relevante para o manejo clínico destes pacientes / Asthma is a chronic inflammatory disorder of the airway with high prevalence that leads functional impairment to health related quality of life (HRQoL). The pathophysiology of asthma is characterized by intense immunoregulation and exercise can play an important role in this inflammatory response due to its immunoregulatory effects. Objective: To evaluate the effect of an aerobic training program on systemic and pulmonary inflammation, clinical control and HRQoL of adult patients with moderate or severe persistent asthma. Methods: Fifty-eight asthmatic adult patients were randomly assigned to either control (CG, n = 28) or training groups (TG, n = 30) and 16 subjects non-asthmatic (NAG). The CG performed an educational program and breathing exercises, while the TG performed all procedures in the CG and an aerobic training program. The immune response was assessed by plasma levels of Th1 cytokines (tumor necrosis factor, interleukin-6 (IL-6), IL-8, Th2 (IL-4, IL-5), regulatory (IL-10) and chemokines (MCP-1, IP-10, MIG, RANTES), either chronically and after a single bout of exercise. Before and after the intervention all patients performed a pulmonary function test, cardiopulmonary exercise testing, clinical control test, HRQoL questionnaire, fractional exhaled nitric oxide (FeNO), induced sputum and blood sample. The NAG performed only the cardiopulmonary exercise test and plasma levels of cytokines. Results: Patients that performed a aerobic training program decreased plasma of interleukin (IL) 6, IL-8 and monocyte chemotactic protein-1 (MCP-1) (p < 0.005). A single bout session of exercise raises the levels of IL-6, IL-8 and IL-5, and then return to baseline one hour after exercise (p < 0.05). IL-10 has also increased immediately after exercise and its levels remained higher even for one hour (p < 0.05). The pulmonary inflammation reduced only GT patients with high levels of eosinophils and FeNO (p < 0.05). The FSRQV, clinical control and physical capacity also improved only in GT (p < 0.05). Conclusion: Our results show that the improvement of the physical capacity of patients with asthma may have an anti-inflammatory effect and may be relevant for the clinical management of these patients

Introdução: A educação em saúde é considerada essencial no controle da asma. A implantação de um programa de educação (PE) com automanejo tem impacto positivo na melhora da qualidade de assistência em asma. Entretanto, os benefícios de um PE ainda são controversos em função das barreiras estruturais. Objetivo: Avaliar o controle clínico de pacientes submetidos a um programa de automanejo associado automonitorização e auto-tratamento comparando-os com dois grupos em atendimento ambulatorial de rotina, com e sem aplicação de um PE. Ainda, mensurar o conhecimento da doença e técnica inalatória, os índices de qualidade de vida, sintomas de ansiedade e depressão e a alfabetização funcional em saúde. Métodos: Trata-se de um estudo aleatorizado, controlado, de grupos paralelos, alocados em três grupos: grupo controle (GC), educação (GE) e automanejo (GA) durante um período de doze meses. Foram incluídos 110 pacientes com asma persistente moderada e grave. O PE foi oferecido para pequenos grupos nos dias de consulta, e consistiu de aulas expositivas divididas em módulos: (1) fisiopatologia e controle ambiental; (2) sinais/sintomas da asma; (3) tratamento e treinamento da técnica inalatória. O GA ainda recebeu um diário de sintomas e um plano de ação individualizado por escrito. Para avaliar o controle da doença foi utilizado a média de pontos do teste de controle da asma (ACT) e o percentual de pacientes com escore 20. Outros questionários incluídos foram: conhecimento sobre a doença (QCA), qualidade de vida relacionada à asma (AQLQ-s), escala hospitalar de ansiedade e depressão (HADS) e o teste de alfabetização funcional (s-TOFHLA). Resultados: Em dois anos, 84 pacientes completaram o estudo. Os grupos eram homogêneos em relação às características basais. A média do ACT aumentou de 14 para 18 pontos, sendo que 48% dos pacientes do GA atingiram o controle da asma. Os GA e GE aumentaram o conhecimento da doença e técnica inalatória para 100%. E os sintomas de ansiedade diminuíram em 14% e 12%, respectivamente. O escore do AQLQ-s foi clinicamente relevante com aumento significativo maior que 0,5 pontos nos dois grupos. O s-TOFLHA foi classificado como alfabetização em saúde adequada com escore médio de 76 pontos. Conclusões: PE associado automanejo durante a rotina de atendimento ambulatorial mostrou impacto relevante sobre a melhora clínica de pacientes portadores de asma moderada e grave. O PE aumentou o conhecimento sobre a doença e tratamento medicamentoso, com melhora da qualidade de vida relacionada à saúde e os sintomas de ansiedade. Nesta população os pacientes apresentaram adequada alfabetização funcional em saúde. / Background: Health education is considered essential in asthma control. The implementation of an education program (EP) with self-management has a positive impact on improving the quality of care in asthma. However, the benefits of an EP are still controversial according of structural barriers. Objective: Evaluate the clinical control of patients submitted a self-management program associated with selfmonitoring and self-treatment comparing with two groups during the routine outpatient visits with and without the EP application. Also, measure the disease knowledge and inhalation technique, the indices of quality of life, symptoms of anxiety and depression and functional health literacy. Methods: This was a randomized study, controlled, divided into three groups: control group (CG), education (EG) and self-management (AG) during twelve months. The study included 110 patients with moderate and severe persistent asthma. The EP was applied to small groups on outpatient visit days, consisted of lectures divided into three parts: (1) pathophysiology and environmental control; (2) asthma symptoms; (3) treatment and training in the inhalation technique. The AG also received a symptoms diary card and written personal asthma action plan. Disease control was measured by the score of asthma control test (ACT) and the percentage of patients with scores 20. Other questionnaires included: disease knowledge (UDQ), asthma quality of life (AQLQ-s), hospital anxiety and depression scale (HADS) and functional literacy health test (s- TOFHLA). Results: In two years, 84 patients completed the study. Groups were similar in baseline characteristics. The mean ACT increased from 14 to 18 points, with 48% of patients in the AG achieved better control of asthma. The AG and EG increased disease knowledge and inhalation technique up to 100%. And the anxiety symptoms decreased 14% and 12%, respectively. The AQLQ-s score was clinically relevant with a significant increase of more than 0.5 points in both groups. The s- TOFLHA was classified as adequate health literacy with a mean score of 76 points. Conclusions: EP associated with self-management during routine outpatient visit showed significant impact on the clinical improvement in patients with moderate to severe asthma. The EP increased knowledge about the disease and drug treatment, with improvement in quality of life and symptoms of anxiety. In this population patients had adequate functional health literacy.

Introdução: A educação em saúde é considerada essencial no controle da asma. A implantação de um programa de educação (PE) com automanejo tem impacto positivo na melhora da qualidade de assistência em asma. Entretanto, os benefícios de um PE ainda são controversos em função das barreiras estruturais. Objetivo: Avaliar o controle clínico de pacientes submetidos a um programa de automanejo associado automonitorização e auto-tratamento comparando-os com dois grupos em atendimento ambulatorial de rotina, com e sem aplicação de um PE. Ainda, mensurar o conhecimento da doença e técnica inalatória, os índices de qualidade de vida, sintomas de ansiedade e depressão e a alfabetização funcional em saúde. Métodos: Trata-se de um estudo aleatorizado, controlado, de grupos paralelos, alocados em três grupos: grupo controle (GC), educação (GE) e automanejo (GA) durante um período de doze meses. Foram incluídos 110 pacientes com asma persistente moderada e grave. O PE foi oferecido para pequenos grupos nos dias de consulta, e consistiu de aulas expositivas divididas em módulos: (1) fisiopatologia e controle ambiental; (2) sinais/sintomas da asma; (3) tratamento e treinamento da técnica inalatória. O GA ainda recebeu um diário de sintomas e um plano de ação individualizado por escrito. Para avaliar o controle da doença foi utilizado a média de pontos do teste de controle da asma (ACT) e o percentual de pacientes com escore 20. Outros questionários incluídos foram: conhecimento sobre a doença (QCA), qualidade de vida relacionada à asma (AQLQ-s), escala hospitalar de ansiedade e depressão (HADS) e o teste de alfabetização funcional (s-TOFHLA). Resultados: Em dois anos, 84 pacientes completaram o estudo. Os grupos eram homogêneos em relação às características basais. A média do ACT aumentou de 14 para 18 pontos, sendo que 48% dos pacientes do GA atingiram o controle da asma. Os GA e GE aumentaram o conhecimento da doença e técnica inalatória para 100%. E os sintomas de ansiedade diminuíram em 14% e 12%, respectivamente. O escore do AQLQ-s foi clinicamente relevante com aumento significativo maior que 0,5 pontos nos dois grupos. O s-TOFLHA foi classificado como alfabetização em saúde adequada com escore médio de 76 pontos. Conclusões: PE associado automanejo durante a rotina de atendimento ambulatorial mostrou impacto relevante sobre a melhora clínica de pacientes portadores de asma moderada e grave. O PE aumentou o conhecimento sobre a doença e tratamento medicamentoso, com melhora da qualidade de vida relacionada à saúde e os sintomas de ansiedade. Nesta população os pacientes apresentaram adequada alfabetização funcional em saúde. / Background: Health education is considered essential in asthma control. The implementation of an education program (EP) with self-management has a positive impact on improving the quality of care in asthma. However, the benefits of an EP are still controversial according of structural barriers. Objective: Evaluate the clinical control of patients submitted a self-management program associated with selfmonitoring and self-treatment comparing with two groups during the routine outpatient visits with and without the EP application. Also, measure the disease knowledge and inhalation technique, the indices of quality of life, symptoms of anxiety and depression and functional health literacy. Methods: This was a randomized study, controlled, divided into three groups: control group (CG), education (EG) and self-management (AG) during twelve months. The study included 110 patients with moderate and severe persistent asthma. The EP was applied to small groups on outpatient visit days, consisted of lectures divided into three parts: (1) pathophysiology and environmental control; (2) asthma symptoms; (3) treatment and training in the inhalation technique. The AG also received a symptoms diary card and written personal asthma action plan. Disease control was measured by the score of asthma control test (ACT) and the percentage of patients with scores 20. Other questionnaires included: disease knowledge (UDQ), asthma quality of life (AQLQ-s), hospital anxiety and depression scale (HADS) and functional literacy health test (s- TOFHLA). Results: In two years, 84 patients completed the study. Groups were similar in baseline characteristics. The mean ACT increased from 14 to 18 points, with 48% of patients in the AG achieved better control of asthma. The AG and EG increased disease knowledge and inhalation technique up to 100%. And the anxiety symptoms decreased 14% and 12%, respectively. The AQLQ-s score was clinically relevant with a significant increase of more than 0.5 points in both groups. The s- TOFLHA was classified as adequate health literacy with a mean score of 76 points. Conclusions: EP associated with self-management during routine outpatient visit showed significant impact on the clinical improvement in patients with moderate to severe asthma. The EP increased knowledge about the disease and drug treatment, with improvement in quality of life and symptoms of anxiety. In this population patients had adequate functional health literacy.