Health education and self-care in primary health care in patients with type 2 diabetes mellitus: protocol for a randomized clinical trial

Health education and self-care in primary health care in patients with type 2 diabetes mellitus: protocol for a randomized clinical trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Health education and self-care in primary health care in patients with type 2 diabetes mellitus: protocol for a randomized clinical trial Luciane Bisognin Ceretta, Vanessa Miranda, Lucas Helal, Andriele Vieira, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3249763/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective : Testing a model of Health Education and self-care, based on the transtheoretical model of behavior change by Prochaska and DiClemente, on glycemic control, and important clinical and behavioral variables, against usual care, in patients with difficult-to-manage Type 2 Diabetes Mellitus. Methods : randomized, parallel, phase III clinical trial, with allocation ratio of 1:1, duration of 6 months, with primary endpoint HbA1c (%) between groups at the end of 6 months. The RCT will be conducted in the assigned territory of the patients, in order to reinforce the student-educator bond and the adherence of patients to the trial. Statistical Analysis Plan : descriptive analyses will be presented in continuous and categorical data, accompanied by the respective dispersion measures. Hypothesis tests will be performed for inferential analysis. For all conclusions related to primary and secondary endpoints, the intention-to-treat principle will be used as the primary analysis, accompanied by per-protocol analyses. Generalized linear models or mixed effects models will be used depending on the pattern of missing data found arising from intra-unit variability. Three interim safety reviews will be scheduled, performed by an independent panel, for potential early termination due in the case of harm, in accordance with the rules established by the study for patient safety. Stata 17.0.0 and R 4.3.1 statistical packages will be used for analysis, graphs, and figures. Test registration number: Brazilian Registry of Clinical Trials (RBR-5w2sqt); Pre-results. Primary Care Diabetes Mellitus Type 2 Health education Self-care Behavior change Glycemic Control Figures Figure 1 Introduction Diabetes Mellitus (DM) is a group of diseases that causes disturbances in the secretion and/or use of insulin by the body. In type 1 diabetes mellitus (DM1), autoimmune destruction of pancreatic cells and insulin deficiency occur. In type 2 diabetes mellitus (DM2), there are defects in insulin action and secretion and in hepatic glucose regulation [ 1 ]. Both present hyperglycemia, but the pathophysiological alterations are present even before the abnormal glycemic values. In addition, these patients present metabolic disorders characterized by hyperglycemia, resulting from a defect in the secretion and/or action of insulin [ 2 , 3 ]. According to the World Health Organization (WHO), DM is considered an epidemic, being one of the most prevalent Chronic Noncommunicable Diseases (NCDs) in the world. There are more than 463 million adults with DM. The global prevalence is around 9.3%, with a predominance of DM2 (90%) [ 4 ]. In Brazil, there are more than 16.8 million people with DM and, according to the Longitudinal Study of Adult Health (ELSA – Brazil), 50% of individuals identified with diabetes are unaware of the diagnosis [ 5 ]. In Brazil, according to the 2019 National Health Survey (PNS), DM affects 7.7% of the individuals interviewed, being higher among women (8.4%) than among men (6.9%). The frequency tends to be higher with increasing age, with 19.9% among people aged 60 to 74 years and 21.1% among people aged 75 years or older [ 6 ]. Between 1990 and 2017, DM went from the 11th leading cause of death to the 3rd leading cause of death in the country [ 7 ]. In addition, the South region has the second highest DM-specific mortality rate [ 8 ]. In 2017, other non-communicable chronic diseases were the seventh leading cause of DALYs (Disability Adjusted Life Years), with diabetes representing 4.7% of total DALYs and 6.1% of DALYs due to NCDs. Cardiovascular diseases were the main cause of DALY in that same year. In the case of Years of life lost (YLL), diabetes represents the seventh leading cause, 4.5% of total YLLs and 6.9% of YLLs due to NCDs. Ischemic heart disease and cerebrovascular disease are the second and third causes, respectively [ 9 – 11 ]. DM is also a disease with a great impact on health costs, due to long-term treatment costs, hospitalizations, and loss of productivity. Considering hospitalizations, studies show costs of BRL 83,659,862 in hospitalizations for DM and BRL 462,989,157 in hospitalizations for DM and causes attributable to DM. Among the attributable causes are: cardiovascular (coronary and cerebrovascular disease), kidney, eye, neurological (diagnoses related to diabetic neuropathy), and infectious diseases (urinary and respiratory infections), and neoplasms (breast cancer, endometrium, pancreas, colorectal cancer, hepatocellular carcinoma, and cholangiocarcinoma) [ 12 ]. In addition, according to the International Diabetes Federation (IDF), in 2021, Brazil occupied the 6th position among the countries with the highest number of people with diabetes – more than 15.7 million – and the highest health cost – more than USD 50 billion. Other authors who studied the costs of the Unified Health System presented approximate total costs of US $ 15.67 billion per year. Of this amount, 44% was related to direct costs, 23.6% to non-medical costs (dietary products and transport), and 32.4% to indirect costs, absenteeism, and early retirement [ 12 , 13 ]. Given this scenario, it is recognized that DM is a complex management condition with a great socioeconomic impact. Pharmacological and non-pharmacological treatments should be adopted in order to guarantee the quality of life and low rates of comorbidities of individuals with DM. Treatment measures include several therapeutic classes and technologies. The treatment measures presented by the Guideline of the Brazilian Society of Diabetes (2019–2020), include diabetes education as one of the lifestyle measures for DM [ 14 ]. DM education is the process of developing new skills that allow the person with diabetes to be the protagonist of decisions on their treatment, with objectives related to quality of life, improvement in clinical results, and a reduction in barriers in the relationships of the individual with DM. In the case of DM, these strategies promote behavioral changes through information, education, and interpersonal communication [ 14 ]. From the understanding of behavior, these strategies should be planned as a process centered on the individual with DM and adapted to their goals and sociocultural context. On the other hand, DM education, according to the 2019/20 Guideline of the Brazilian Society of Diabetes, is the Transtheoretical Model of Behavior Change proposed by Prochaska et al. [ 14 ]. The model is presented through five stages covered by the individual with DM, who is denominated ‘the student’ during this process, in order to change their behavior. The first stage is pre-contemplation, in which the individual is not yet aware of the problem or does not treat it as a priority, therefore, they do not change their attitude. Then, in the contemplation stage, the identification of the problem takes place, generating a discussion (internal/external) about the need for change. Despite being aware of the need, the individual is thinking about the pros and cons. The third stage is called preparation, in which the determination to start the process is present and the definition of strategies begins. The penultimate stage is action. At this stage, concrete decisions about changing behavior take place and attitudes become apparent. It is not uncommon for there to be relapses at this stage. Finally, the fifth stage is maintenance, which requires greater effort from the individual not to return to the previous behavior [ 15 ]. These stages of the model proposed by Prochaska and his collaborators are dynamic and serve to understand the student's needs and promote their autonomy in the process. In turn, the student can regress and advance on the scale in a non-linear way. In this sense, the educator's understanding for the elaboration of strategies is essential. Transtheoretical models have been studied for some years in the health area. For diabetes, researchers found significant changes in overall treatment and nutrition counseling [ 16 ] Despite the need for DM education actions for the clinical management of this condition and the achievement of therapeutic goals, these strategies are a challenge for public health, given the great demand from health teams. On the other hand, achieving the desired results with these actions would lead to great resolution for the condition at all levels of complexity. Especially for Primary Health Care, in which resolving chronic conditions is considered one of the performance indicators [ 17 ]. Health education, as a multifaceted model, contributes to health care actions at an individual and collective level. However, there are several reports of health education as a prohibitionist and reductionist practice of the individual's protagonism. Therefore, it is essential that health education permeates the training of professionals and the construction of public policies that include integrated actions between professionals and service users. It is believed that all health professionals are able to carry out health education activities, especially professionals who work in the family health team, due to their proximity to the population enrolled in their territory. Hypothesis The implementation of Health Education programs supported by behavior modification strategies is more effective than usual outpatient care on glycemic control and secondary outcomes. Objective To test the effectiveness of a behavior modification program aimed at self-care in DM2 based on the transtheoretical model of Prochaska and DiClemente, in patients with difficult-to-manage DM2, on glycemic control (primary outcome – difference between groups in HbA1c variation (%) at 3 and 6 months), and clinical, functional, and behavioral outcomes of relevance. Materials and Methods Randomized clinical trial (RCT), phase III, pragmatic, superiority, in parallel, with allocation ratio 1:1, blinded to outcome measurers, multicenter (Unesc/Hospital São José, Criciúma, Santa Catarina), which compares a behavior modification strategy aimed at Health Education/Self-care lasting 6 months in patients with DM2 assisted by the Primary Care of the Unified Health System, without withdrawing them from their assigned territories for any purposes, against patients in usual care (i.e., outpatient routine at their reference Basic Health Unit). The main objective of the RCT is to test the effectiveness of the transtheoretical model of behavior change on glycemic control and other clinically and behaviorally relevant outcomes. Therefore, the project will be carried out in five stages: Document organization; Training; Pilot; Starting and conducting the RCT and Ending (Fig 1). Ethics approval and consent to participate This study was performed in line with the principles of the Declaration of Helsinki. The study is approved by the Research Ethics Committee of the University of Extremo Sul Catarinense and all participants will provide their written informed consent (registration number 48193721.0.0000.0119 and approval number 4.805.666). Test results will be disseminated through peer-reviewed journal articles and conference presentations, reports to organizations involved in PD, and to participants. Study Centers The study is composed of two centers: Universidade do Extremo Sul Catarinense (Unesc) and Hospital São José (HSJ), both located in the city of Criciúma, Santa Catarina, Brazil. The coordinating center is Unesc, while the HSJ is a co-participating center. It is up to the coordinating center to manage all functions inherent to the organization, implementation, ethical and regulatory procedures, conduction, and reporting of the study; while the co-participating center is responsible for reporting major adverse events (MADEs), adverse events (ADEs) and deaths of study participants who may have been referred to the study, as well as the care and center for adjudication of study outcomes. Stage 1 - Documentary organization Here, the project begins with the refinement of the project's internal documentation (construction of electronic and physical forms, REDCap structure, generation of randomization lists); dialogue with the district and local managers of the UBSs in Criciúma, in possession of the Letter of Acceptance issued by the Municipal Health Department/Municipality of Criciúma; finalization of team formation (administrative and operational); lines of contact for the study; creation of the study's visual identity; implementation of the post-doctoral and scientific initiation scholarships received by the project; ordering of supplies for start-up; pilot. The project will take place entirely in the patients' assigned territory - that is, recruitment will take place through active recruitment, via review of medical records, by users of the network; data collection will take place at the patient's UBS of reference; the intervention will take place at the UBS and in community devices also in the patient's territory, justifying the team's interlocution. Registration of the clinical trial on ClinicalTrials.gov or the International Clinical Trials Registry Platform (ICTRP). There is a Data Monitoring Committee (DMC) and a Medical Board (JM) for the study. Stage 2 - Training In stage 2, the project team will be trained: a) administrative: recruitment, notifications, technical support, etc.; b) operational: data collection team; intervention team; supervisors. A manual will also be developed for standardizing interventions and measuring outcomes, as well as their respective testing during the pilot. There will also be the implementation of a reference model of the Health Education program to be adapted patient by patient Stage 3 - Pilot At this stage, it is expected that the pilot period, with all the stages of the actual RCT having been completed, will have been finalized, either at a reference UBS or at Unesc. The interventions will not be conducted until their predetermined time, but will be tested session by session, in particular. It is expected that procedures, equipment, records and all workflows will have been tested, corrected and that they will be ready for the start of the ECR. With this, it is also hoped that all the procedures will be finalized so that the protocol article can be prepared for submission to a peer-reviewed journal. Stage 4 - Eligibility criteria Participants who meet the inclusion criteria and are willing to provide written informed consent prior to the start of the study will be considered eligible. Participants will be informed that they can withdraw from the study at any time and that their withdrawal will not affect their care or inclusion in future studies. Inclusion criteria Eligible subjects who meet all of the following criteria at the time of randomization will be included in the study: a) Being an outpatient assisted by the SUS Primary Care network, having been attended by the care team for at least one year before randomization; b) Behavior Change Readiness Stage: The initial classification for eligibility will consider any patient in the pre-action stage (pre-contemplation, contemplation, or preparation). In order to determine which stage of change for self-care practices the participants is in at the beginning of the study, as well as at other assessment times, the definition of DM self-care will be briefly explained to them: “ DM self-care is the knowledge, skills, and ability to self-manage the needs imposed by the disease whenever possible. ” For this study, the habits incorporated into self-care are related to items in the Diabetes Self-Care Management Questionnaire , Brazilian version (DSMQ-R) [18]: a) blood glucose management; b) dietary control; c) physical activity; d) health monitoring. After offering the concept of self-care in DM to the study patients, the participants will be asked the following question: " Do you effectively practice diabetes self-care in your daily life ?" [19]. Five response categories will be available, placing participants in one of five stages of change to self-care: pre-contemplation (“ not intending to start in the next 6 months ”), contemplation (“ intending to start in the next 6 months ”), preparation (“ intending to start in the next 30 days ”), action (practicing the behavior, but for less than 6 months) or maintenance (practicing the behavior for at least 6 months) [20]. This strategy will be used to classify the initial stage of patients and also to guide the professional responsible for the patient in the progression of stages over the 6 months (0, and 6 months of the RCT). c) Diagnosis of DM2: confirmed by examination of HbA1c ≥ 6.5% in the 3 months prior to the date of randomization; note : the inclusion criteria for use of medication (oral hypoglycemic agent or insulin) or clinical diagnosis will be disregarded due to redundancy, considering the following inclusion criteria. d) * Difficult to manage DM2: recorded in medical records as such OR ; recorded in medical records as a patient with poor medication adherence OR ; one or more co-morbidities excluding cardiovascular disease (CVD); OR at least one episode of hypoglycemia requiring third-party help or hypoglycemic coma; OR one or more stable CVDs; OR one or more CV risk factors; OR one or more microvascular disorders (diabetic proliferative retinopathy excluded); Exclusion criteria Participants who meet any of the following criteria will be excluded: Pregnant women (regardless of gestational DM); HIV/AIDS; Use of erythropoietin, volume loss, blood transfusion, or recent severe anemia; Patients with CVD on non-optimized treatment OR CVD procedure in the last 3 months; Proliferative macular disease associated with diabetes; Patients participating in another study at the same time; Patients residing with other patients enrolled in the D-CARE Study. Interventions for each group Intervention group: behavior change Interventions will occur in groups, with randomization into groups of 8 people. Patients randomized to the intervention group will attend 1 weekly meeting at their reference ESF/UBS or community unit connected to the territory, for 6 months. All patients in the study, as stated in the eligibility criteria, will be required to start in the pre-action stage (pre-contemplation, contemplation, or preparation), and professional psychologists will guide the group sessions with the intention of leading the participants to the stage of action/maintenance. In the pre-contemplation, contemplation, and preparation phases, it is usually indicated that transitions can occur in 6, 6, and 1 month, respectively, however, the time for transition may be shorter and, at the discretion of the professional psychologist, a patient in contemplation, for example, can already switch to the action phase. Particularly in group interventions, the participants who follow through may be at different stages. There is also the possibility of relapses and recurrences, in which patients return to previous stages. Thus, for the pre-contemplation, contemplation, and preparation phases, patients are at the discretion of the psychologist to consider changing the phase (i.e., at this moment, the psychologist should apply the tool based on the guiding behavior question for reclassification of the patient's behavior stage) and direction of content. The professional responsible for group interventions must necessarily identify the particularities of each individual and direct the dynamics so that each individual contributes to the group with sensations, implications, challenges, and experiences according to the phase they are in. This happens on purpose, so that the group bond is not lost, and for patients in more advanced stages (or vice versa) to help their peers in the progression of stages. Tentatively, the professional will try to lead the group to evolve at the same pace, with therapeutic mechanisms to reach a balance. However, heterogeneity within the group is expected and is inherent to the type of intervention. Longitudinally, the behavior stages of the patients reclassified at 3 months and 6 months. During the study, after the participants understand the concept of self-care in DM, the following question will be repeated to the participants: " Do you effectively practice diabetes self-care in your daily life? " [19]. Five response categories will be available, placing participants in one of five stages of self-care: pre-contemplation (“ not intending to start in the next 6 months ”), contemplation (“ intending to start in the next 6 months ”), preparation (“ not intending to start in the next 30 days ”), action ( practicing the behavior, but for less than 6 months ), or maintenance ( practicing the behavior for at least 6 months ) [20]. This strategy will be used to classify patients in their initial stage and also to guide the professional responsible for the patient in the progression of stages over the 6 months. The professional conducting the sessions should use the processes suggested by Prochaska and DiClemente for each given stage of behavior change. The processes are affective and emotional domains that approach the behavior to be changed - in our case, self-care - from different perspectives. For example, in the pre-contemplation stage, awareness, dramatic relief, reassessment of perceived environment, and self-reassessment are included, with weighting on the pros of adhering to an autonomous and decisional self-care routine. From the 9th meeting, patients will receive visits from a multidisciplinary health team to address topics related to self-care, previously instructed and coordinated by a professional psychologist to respect the affective and emotional contents of each indicated process. This will help the professional who coordinates the group with the stage transition when addressing themes that, in the future, will be the target of action and maintenance, and that sometimes patients have already experienced in life as successful or failed experiences. At the end of each session, specific tasks will be given to the patients, which will be resumed in the next meeting. For patients in a period of action, specific and intensive recommendations will be given for each habit domain that makes up self-care, based on the Standards of Medical Care of the American Diabetes Association 2021 (ADA) for self-care in DM2 and in the four domains of self-care in diabetes that involve blood glucose management, food and medication management, physical activity, and the use of health services. In the case of relapses, the patient will be reassessed by the study team to correctly identify which phase hey are in and resume the content according to their status and indications for relapse. Control group: usual care Patients randomized to the usual care group will follow their usual outpatient routine for the same duration of the study, but will be evaluated in the same way (outcomes, times, etc.) as patients in the intervention group. Criteria for discontinuation Participants will be required to complete a minimum of 22 of the 27 scheduled training sessions (i.e. >80% participation) during the 6-month intervention period. If the patient misses a session, they will have the opportunity to complete an additional session to make up the missed training. Adherence will be recorded through attendance sheets, which will be filled out after each training session by the coordinating researcher of the intervention group. With respect to the participants in the control group, they will be expected to attend the laboratory every time they are recruited, for the collection of biochemical tests every 3 months, and for the collection of other data after 6 months. If an adverse event is deemed to have a causal relationship to the intervention and raises concern about participant safety, the intervention will be discontinued for the participant. Relevant concomitant care and interventions To ensure that the only difference between groups is the clinical trial intervention, participants will be instructed not to make any dietary changes or engage in any formal exercise program during the study. Trial Status The initial protocol presented to the federal government in the project was longer, lasting 18 months (Protocol 1), and this version was applied to the pilot group that was not yet registered with Clinical Trials. As mentioned above, after seeing the pilot run and based on the literature, the protocol was adjusted to the version described here (Protocol 2). Therefore, the study was registered at www.clinicaltrials.gov, with the number NCT05969015 dated July 3, 2023, with recruitment starting in July and this phase expected to end in December 2023. Outcomes For the efficacy variable, the outcome used will be the maintenance of basal glycated hemoglobin control for 6 months. In addition, relevant clinical, functional, and behavioral outcomes will be considered at 6 months, including: estimating glycemic control, renal function, and lipid profile; estimating intercurrences attributable or not to DM2; estimating pressure control, body weight, anthropometry, adherence to pharmacological treatment; estimating total physical activity, in leisure, and in domestic and incidental activities; functional capacity, depression and anxiety scores; estimating adherence to the intervention; estimating the occurrence of behavior changes, their respective stages, and average times for occurrence; estimating the percentage of participants in action and/or maintenance at the end of 6 months; estimating the magnitude of changes in habits that make up the behavior; estimating the occurrence of adverse events of interest related or not to the study; developing a strategy for implementation of the protocol, if it proves to be effective, in all national primary care. Stage 5 - Finalization Finalization of the RCT, reporting to CNPq and other entities, notification to the Unesc and HSJ Research Ethics Committee, closing of the register at www.clinicaltrials.gov, processing of the data, delivery of the results to the patients, delivery of the results to the municipal government and the funding body, CNPq, publication of the results on a non-peer-reviewed publication server (preprints), press-releases (in accordance with the study's press-release policy) and preparation of the manuscript with the main results of the study. Statistical Analysis Plan Descriptive statistics will be presented in continuous and categorical data, accompanied by the respective dispersion measures. Hypothesis tests will be performed for inferential analysis. For all conclusions related to primary and secondary endpoints, the intention-to-treat principle will be used as the primary analysis, accompanied by per-protocol analyses. Generalized linear models or mixed effects models will be used depending on the pattern of missing data found from the intra-unit variability. Three interim safety reviews will be scheduled, performed by an independent panel, for potential early termination due to harm, if this is the case, in accordance with the rules established by the study for patient safety. Stata 17.0.0 and R 4.3.1 statistical packages will be used for analysis, graphs, and figures. Discussion The construction of a health system is a continuous process that involves the construction and change of public policies and social participation. In this sense, strategies are needed to reorient the care model, defined by Paim as “[...] a way of combining techniques and technologies to solve problems and meet individual and collective health needs. It is a reason for being, a rationality, a kind of 'logic' that guides action" [21]. The action of the family health team aims to ensure integrality in health, which among its concepts means ensuring assistance, curative actions, and above all, prevention and health promotion. In this sense, health education is presented as a tool for reorienting the health care model and sharing therapeutic goals between the health team and the patient, presenting itself as an essential therapeutic strategy in the non-pharmacological treatment of chronic conditions. The results pointed out by the IDF Diabetes Atlas, released in 2019, point out that there is still a long way to go in reducing the global impact of diabetes [22]. Among the various therapeutic plans common to chronic diseases, health education stands out in the sense of making the individual the protagonist in the management of their health condition and self-care [14]. However, promoting health care through health education strategies is still a major challenge for all levels of primary care. Although educational practices are a good alternative to compose the care model for people with DM, studies show the low impact of these models on adherence to self-care. It is important that DM education be carried out based on models that promote the individual's adherence to the care process and equip them to manage their condition [23]. In this sense, the bond between educator and student as an effective strategy is important, promoting the co-responsibility of the student and the continuity and longitudinality of care. Especially for family health teams, work overload and the large number of outpatient procedures make it difficult to pay attention to preventive care strategies. In this way, innovative strategies that point to a reduction in the bureaucracy of care processes, such as the use of technologies in order to bring the health team closer to the family and the enrolled population, point to the agility of the processes. In addition, with the change in the SUS financing model, the Previne Brasil program, within the incentive criteria for strategic actions, recommends via technical note nº 7/2022-SAPS/MS, the definition of the proportion of people with diabetes, with a consultation and glycated hemoglobin requested within 6 months, and a goal established for this indicator of 50% of population coverage, since the glycated hemoglobin test allows estimation of the prognosis and performance of the appropriate therapeutic adjustment, with a view to reducing morbidity and mortality due to DM. Therefore, therapeutic plans that enhance the strategies to achieve this goal, directly contribute to the strengthening of PHC and its ability to resolve chronic conditions. Declarations Ethics approval and consent to participate This study was performed in line with the principles of the Declaration of Helsinki. The study is approved by the Research Ethics Committee of the University of Extremo Sul Catarinense and all participants will provide their written informed consent (registration number 48193721.0.0000.0119 and approval number 4.805.666). Test results will be disseminated through peer-reviewed journal articles and conference presentations, reports to organizations involved in PD, and to participants. Consent for publication All participants consented to participation in this study. Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests, Funding Not aplicaded Author contributions Conceptualization: Luciane Bisognin Ceretta, Lucas Helal and Andriele Vieira; Writing – original draft: Vanessa Iribarrem Avena Miranda; Lucas Helal; Andriele Vieira; Lisiane Generoso Tuon; Joni Marcio de Farias. Writing (review and editing): Vanessa Iribarrem Avena Miranda and Cristiane Damiani Tomasi. All authors read and approved the final manuscript. Acknowledgements The authors thank the Universidade do Extremo Sul Catarinense (UNESC) and Conselho Nacional de Desenvolvimento Científico e Tecnológico References International Diabetes Federation (IDF). Diabetes Atlas. 7th Edition, International Diabetes Federation, Brussels, Belgium. 2015. American Diabetes Association. Diagnosis and classification of diabetes mellitus. 2010, 33, Suppl 1: S62-S69. doi: 10.2337/dc10-S062 Corrêa K, Gouvêa GR, Silva MAV, Possobon RF, Barbosa LFLN, Pereira AC et al. Qualidade de vida e características dos pacientes diabéticos. Ciênc. saúde colet. 2017; 22:921-930. doi: 10.1590/1413-81232017223.24452015 World Health Organization (WHO). Global report on diabetes: executive summary. In . : World Health Organization. 2016. Schmidt MI, Hoffmann JF, de Fátima Sander Diniz M, Lotufo PA, Griep RH, Bensenor IM et al. 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Int J Environ Res Public Health. 2018; 15(1): 89. doi: 10.3390/ijerph15010089 Forti A, Pires A, Pittito B, Gerchman F, Oliveira J, Zajdenverg LJ. Diretrizes da Sociedade Brasileira de Diabetes 2019-2020 [Internet]. 2020. Prochaska JM, Prochaska JO, Levesque DA. A transtheoretical approach to changing organizations. Adm Policy Ment Health. 2001; 28(4):247-262. doi: 10.1023/a:1011155212811 McKee G, Bannon J, Kerins M, FitzGerald G. Changes in diet, exercise and stress behaviours using the stages of change model in cardiac rehabilitation patients. Eur J Cardiovasc Nurs. 2007; 6(3):233-240.doi: 10.1016/J.EJCNURSE.2006.10.002 Machado MFAS, Monteiro EMLM, Queiroz DT, Vieira NFC, Barroso MGT. Integralidade, formação de saúde, educação em saúde e as propostas do SUS: uma revisão conceitual. 2007, 12:335-342. doi: 10.1590/S1413-81232007000200009 Schmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013; 11:1-14. doi: 10.1186/1477-7525-11-138 Velicer WF., Prochaska JO, Fava JL, Norman, GJ, Redding CA. (1998). Smoking cessation and stress management: Applications of the transtheoretical model of behavior change. Homeostasis in Health and Disease, 38(5-6), 216–233. https://psycnet.apa.org/record/1998-12149-001 Evers KE, Prochaska JO, Johnson JL, Mauriello LM, Padula JA, Prochaska JM. A randomized clinical trial of a population-and transtheoretical model-based stress-management intervention. Health Psychol. 2006; 25(4):521. doi: 10.1037/0278-6133.25.4.521 Paim JS. A reforma sanitária e os modelos assistenciais. In: Epidemiologia & saúde. edn.; 1993: pp 455-466. International Diabetes Federation (IDF) (2015) Diabetes Atlas. 7th Edition, International Diabetes Federation, Brussels, Belgium. 2019. Borges SAC, Porto PN. Por que os pacientes não aderem ao tratamento? Dispositivos metodológicos para a educação em saúde. Saúde debate. 2014; 38:338-346. doi: 10.5935/0103-1104.20140031 Supplementary Files SPIRITFigure.doc FillableSPIRITChecklistFINALOK.pdf Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3249763","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":263476099,"identity":"00aef13d-052a-4ba2-bb63-3f8dffdbb742","order_by":0,"name":"Luciane Bisognin Ceretta","email":"","orcid":"","institution":"Universidade do Sul Extremo Catarinense: Universidade do Extremo Sul Catarinense","correspondingAuthor":false,"prefix":"","firstName":"Luciane","middleName":"Bisognin","lastName":"Ceretta","suffix":""},{"id":263476100,"identity":"528fcbb9-2fab-4bb0-a512-9790c56d5ad6","order_by":1,"name":"Vanessa Miranda","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA1UlEQVRIiWNgGAWjYBADHgZm5gNAWkKGFC1sCSAtPCRZZADRSwgYHD978OGPP3Yy5u08n1/dqLHgYWA/fHQDXi1n8pKNeduSeWQO826zzjkGdBhPWtoNfFokG3LMpBkbmHkkmHm3GeewAbVI8Jjh19L/xvznjz/1QC08z4xz/hGhhV8ix4yBh+0wSAvz49w2orS8MZbmbTsO1MJmxpzbJ8HDRsgvbPw5hh9//Km2l+A//Phzzrc6OX72w8fwakHRLgEmiVUOAswfSFE9CkbBKBgFIwcAACF+O5T5pMznAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-9156-5036","institution":"Universidade do Extremo Sul Catarinense","correspondingAuthor":true,"prefix":"","firstName":"Vanessa","middleName":"","lastName":"Miranda","suffix":""},{"id":263476101,"identity":"0d136ced-d5a6-4048-804d-9f3eedcdce08","order_by":2,"name":"Lucas Helal","email":"","orcid":"","institution":"Unesc: Universidade do Extremo Sul 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1","display":"","copyAsset":false,"role":"figure","size":20389,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCONSORT flowchart of participants’ progress through the study. \u003c/strong\u003eThe sample was calculated based on the population with type 2 diabetes treated in the city in the year 2023.\u003c/p\u003e","description":"","filename":"Onlinefloatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-3249763/v1/a6ddd8addd5f99a2cb32ef96.png"},{"id":49996653,"identity":"5921adcb-b3f3-47a6-874c-87fce72361f7","added_by":"auto","created_at":"2024-01-22 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19:18:30","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":280619,"visible":true,"origin":"","legend":"","description":"","filename":"FillableSPIRITChecklistFINALOK.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3249763/v1/0b277885f8a9eb4118ff7076.pdf"}],"financialInterests":"","formattedTitle":"Health education and self-care in primary health care in patients with type 2 diabetes mellitus: protocol for a randomized clinical trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eDiabetes Mellitus (DM) is a group of diseases that causes disturbances in the secretion and/or use of insulin by the body. In type 1 diabetes mellitus (DM1), autoimmune destruction of pancreatic cells and insulin deficiency occur. In type 2 diabetes mellitus (DM2), there are defects in insulin action and secretion and in hepatic glucose regulation [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Both present hyperglycemia, but the pathophysiological alterations are present even before the abnormal glycemic values. In addition, these patients present metabolic disorders characterized by hyperglycemia, resulting from a defect in the secretion and/or action of insulin [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAccording to the World Health Organization (WHO), DM is considered an epidemic, being one of the most prevalent Chronic Noncommunicable Diseases (NCDs) in the world. There are more than 463\u0026nbsp;million adults with DM. The global prevalence is around 9.3%, with a predominance of DM2 (90%) [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. In Brazil, there are more than 16.8\u0026nbsp;million people with DM and, according to the Longitudinal Study of Adult Health (ELSA \u0026ndash; Brazil), 50% of individuals identified with diabetes are unaware of the diagnosis [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn Brazil, according to the 2019 National Health Survey (PNS), DM affects 7.7% of the individuals interviewed, being higher among women (8.4%) than among men (6.9%). The frequency tends to be higher with increasing age, with 19.9% among people aged 60 to 74 years and 21.1% among people aged 75 years or older [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Between 1990 and 2017, DM went from the 11th leading cause of death to the 3rd leading cause of death in the country [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. In addition, the South region has the second highest DM-specific mortality rate [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn 2017, other non-communicable chronic diseases were the seventh leading cause of DALYs (Disability Adjusted Life Years), with diabetes representing 4.7% of total DALYs and 6.1% of DALYs due to NCDs. Cardiovascular diseases were the main cause of DALY in that same year. In the case of Years of life lost (YLL), diabetes represents the seventh leading cause, 4.5% of total YLLs and 6.9% of YLLs due to NCDs. Ischemic heart disease and cerebrovascular disease are the second and third causes, respectively [\u003cspan additionalcitationids=\"CR10\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDM is also a disease with a great impact on health costs, due to long-term treatment costs, hospitalizations, and loss of productivity. Considering hospitalizations, studies show costs of BRL 83,659,862 in hospitalizations for DM and BRL 462,989,157 in hospitalizations for DM and causes attributable to DM. Among the attributable causes are: cardiovascular (coronary and cerebrovascular disease), kidney, eye, neurological (diagnoses related to diabetic neuropathy), and infectious diseases (urinary and respiratory infections), and neoplasms (breast cancer, endometrium, pancreas, colorectal cancer, hepatocellular carcinoma, and cholangiocarcinoma) [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn addition, according to the International Diabetes Federation (IDF), in 2021, Brazil occupied the 6th position among the countries with the highest number of people with diabetes \u0026ndash; more than 15.7\u0026nbsp;million \u0026ndash; and the highest health cost \u0026ndash; more than USD 50\u0026nbsp;billion. Other authors who studied the costs of the Unified Health System presented approximate total costs of US \u003cspan\u003e$\u003c/span\u003e15.67\u0026nbsp;billion per year. Of this amount, 44% was related to direct costs, 23.6% to non-medical costs (dietary products and transport), and 32.4% to indirect costs, absenteeism, and early retirement [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eGiven this scenario, it is recognized that DM is a complex management condition with a great socioeconomic impact. Pharmacological and non-pharmacological treatments should be adopted in order to guarantee the quality of life and low rates of comorbidities of individuals with DM. Treatment measures include several therapeutic classes and technologies. The treatment measures presented by the Guideline of the Brazilian Society of Diabetes (2019\u0026ndash;2020), include diabetes education as one of the lifestyle measures for DM [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDM education is the process of developing new skills that allow the person with diabetes to be the protagonist of decisions on their treatment, with objectives related to quality of life, improvement in clinical results, and a reduction in barriers in the relationships of the individual with DM. In the case of DM, these strategies promote behavioral changes through information, education, and interpersonal communication [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. From the understanding of behavior, these strategies should be planned as a process centered on the individual with DM and adapted to their goals and sociocultural context.\u003c/p\u003e \u003cp\u003e On the other hand, DM education, according to the 2019/20 Guideline of the Brazilian Society of Diabetes, is the Transtheoretical Model of Behavior Change proposed by Prochaska et al. [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. The model is presented through five stages covered by the individual with DM, who is denominated \u0026lsquo;the student\u0026rsquo; during this process, in order to change their behavior. The first stage is pre-contemplation, in which the individual is not yet aware of the problem or does not treat it as a priority, therefore, they do not change their attitude. Then, in the contemplation stage, the identification of the problem takes place, generating a discussion (internal/external) about the need for change. Despite being aware of the need, the individual is thinking about the pros and cons. The third stage is called preparation, in which the determination to start the process is present and the definition of strategies begins. The penultimate stage is action. At this stage, concrete decisions about changing behavior take place and attitudes become apparent. It is not uncommon for there to be relapses at this stage. Finally, the fifth stage is maintenance, which requires greater effort from the individual not to return to the previous behavior [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThese stages of the model proposed by Prochaska and his collaborators are dynamic and serve to understand the student's needs and promote their autonomy in the process. In turn, the student can regress and advance on the scale in a non-linear way. In this sense, the educator's understanding for the elaboration of strategies is essential. Transtheoretical models have been studied for some years in the health area. For diabetes, researchers found significant changes in overall treatment and nutrition counseling [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eDespite the need for DM education actions for the clinical management of this condition and the achievement of therapeutic goals, these strategies are a challenge for public health, given the great demand from health teams. On the other hand, achieving the desired results with these actions would lead to great resolution for the condition at all levels of complexity. Especially for Primary Health Care, in which resolving chronic conditions is considered one of the performance indicators [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eHealth education, as a multifaceted model, contributes to health care actions at an individual and collective level. However, there are several reports of health education as a prohibitionist and reductionist practice of the individual's protagonism. Therefore, it is essential that health education permeates the training of professionals and the construction of public policies that include integrated actions between professionals and service users. It is believed that all health professionals are able to carry out health education activities, especially professionals who work in the family health team, due to their proximity to the population enrolled in their territory.\u003c/p\u003e \u003cp\u003e \u003cstrong\u003eHypothesis\u003c/strong\u003e \u003cp\u003eThe implementation of Health Education programs supported by behavior modification strategies is more effective than usual outpatient care on glycemic control and secondary outcomes.\u003c/p\u003e \u003c/p\u003e \u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eTo test the effectiveness of a behavior modification program aimed at self-care in DM2 based on the transtheoretical model of Prochaska and DiClemente, in patients with difficult-to-manage DM2, on glycemic control (primary outcome \u0026ndash; difference between groups in HbA1c variation (%) at 3 and 6 months), and clinical, functional, and behavioral outcomes of relevance.\u003c/p\u003e \u003c/div\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003eRandomized clinical trial (RCT), phase III, pragmatic, superiority, in parallel, with allocation ratio 1:1, blinded to outcome measurers, multicenter (Unesc/Hospital S\u0026atilde;o Jos\u0026eacute;, Crici\u0026uacute;ma, Santa Catarina), which compares a behavior modification strategy aimed at Health Education/Self-care lasting 6 months in patients with DM2 assisted by the Primary Care of the Unified Health System, without withdrawing them from their assigned territories for any purposes, against patients in usual care (i.e., outpatient routine at their reference Basic Health Unit). The main objective of the RCT is to test the effectiveness of the transtheoretical model of behavior change on glycemic control and other clinically and behaviorally relevant outcomes. Therefore, the project will be carried out in five stages: Document organization; Training; Pilot; Starting and conducting the RCT and Ending (Fig 1).\u003c/p\u003e\n\u003cp\u003eEthics approval and consent to participate\u003c/p\u003e\n\u003cp\u003eThis study was performed in line with the principles of the Declaration of Helsinki. The study is approved by the Research Ethics Committee of the University of Extremo Sul Catarinense and all participants will provide their written informed consent (registration number 48193721.0.0000.0119 and approval number 4.805.666). Test results will be disseminated through peer-reviewed journal articles and conference presentations, reports to organizations involved in PD, and to participants.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStudy Centers\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe study is composed of two centers: Universidade do Extremo Sul Catarinense (Unesc) and Hospital S\u0026atilde;o Jos\u0026eacute; (HSJ), both located in the city of Crici\u0026uacute;ma, Santa Catarina, Brazil. The coordinating center is Unesc, while the HSJ is a co-participating center. It is up to the coordinating center to manage all functions inherent to the organization, implementation, ethical and regulatory procedures, conduction, and reporting of the study; while the co-participating center is responsible for reporting major adverse events (MADEs), adverse events (ADEs) and deaths of study participants who may have been referred to the study, as well as the care and center for adjudication of study outcomes.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStage 1 - Documentary organization\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHere, the project begins with the refinement of the project\u0026apos;s internal documentation (construction of electronic and physical forms, REDCap structure, generation of randomization lists); dialogue with the district and local managers of the UBSs in Crici\u0026uacute;ma, in possession of the Letter of Acceptance issued by the Municipal Health Department/Municipality of Crici\u0026uacute;ma; finalization of team formation (administrative and operational); lines of contact for the study; creation of the study\u0026apos;s visual identity; implementation of the post-doctoral and scientific initiation scholarships received by the project; ordering of supplies for start-up; pilot. The project will take place entirely in the patients\u0026apos; assigned territory - that is, recruitment will take place through active recruitment, via review of medical records, by users of the network; data collection will take place at the patient\u0026apos;s UBS of reference; the intervention will take place at the UBS and in community devices also in the patient\u0026apos;s territory, justifying the team\u0026apos;s interlocution. Registration of the clinical trial on ClinicalTrials.gov or the International Clinical Trials Registry Platform (ICTRP). There is a Data Monitoring Committee (DMC) and a Medical Board (JM) for the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStage 2 - Training\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn stage 2, the project team will be trained: a) administrative: recruitment, notifications, technical support, etc.; b) operational: data collection team; intervention team; supervisors. A manual will also be developed for standardizing interventions and measuring outcomes, as well as their respective testing during the pilot. There will also be the implementation of a reference model of the Health Education program to be adapted patient by patient\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStage 3 - Pilot\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAt this stage, it is expected that the pilot period, with all the stages of the actual RCT having been completed, will have been finalized, either at a reference UBS or at Unesc. The interventions will not be conducted until their predetermined time, but will be tested session by session, in particular. It is expected that procedures, equipment, records and all workflows will have been tested, corrected and that they will be ready for the start of the ECR. With this, it is also hoped that all the procedures will be finalized so that the protocol article can be prepared for submission to a peer-reviewed journal.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStage 4 - Eligibility criteria\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants who meet the inclusion criteria and are willing to provide written informed consent prior to the start of the study will be considered eligible. Participants will be informed that they can withdraw from the study at any time and that their withdrawal will not affect their care or inclusion in future studies.\u003c/p\u003e\n\u003ch3\u003e\u003cem\u003eInclusion criteria\u003c/em\u003e\u003c/h3\u003e\n\u003cp\u003eEligible subjects who meet all of the following criteria at the time of randomization will be included in the study:\u003c/p\u003e\n\u003cp\u003ea) Being an outpatient assisted by the SUS Primary Care network, having been attended by the care team for at least one year before randomization;\u003c/p\u003e\n\u003cp\u003eb) Behavior Change Readiness Stage: The initial classification for eligibility will consider any patient in the pre-action stage (pre-contemplation, contemplation, or preparation). In order to determine which stage of change for self-care practices the participants is in at the beginning of the study, as well as at other assessment times, the definition of DM self-care will be briefly explained to them: \u0026ldquo;\u003cem\u003eDM self-care is the knowledge, skills, and ability to self-manage the needs imposed by the disease whenever possible.\u003c/em\u003e\u0026rdquo;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor this study, the habits incorporated into self-care are related to items in the \u003cem\u003eDiabetes Self-Care Management Questionnaire\u003c/em\u003e, Brazilian version (DSMQ-R)\u0026nbsp;[18]: a) blood glucose management; b) dietary control; c) physical activity; d) health monitoring. After offering the concept of self-care in DM to the study patients, the participants will be asked the following question: \u0026quot;\u003cem\u003eDo you effectively practice diabetes self-care in your daily life\u003c/em\u003e?\u0026quot;\u0026nbsp;[19].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFive response categories will be available, placing participants in one of five stages of change to self-care: \u003cstrong\u003epre-contemplation\u0026nbsp;\u003c/strong\u003e(\u0026ldquo;\u003cem\u003enot intending to start in the next 6 months\u003c/em\u003e\u0026rdquo;), \u003cstrong\u003econtemplation\u003c/strong\u003e (\u0026ldquo;\u003cem\u003eintending to start in the next 6 months\u003c/em\u003e\u0026rdquo;), \u003cstrong\u003epreparation\u003c/strong\u003e (\u0026ldquo;\u003cem\u003eintending to start in the next 30 days\u003c/em\u003e\u0026rdquo;), \u003cstrong\u003eaction\u003c/strong\u003e (practicing the behavior, but for less than 6 months) or \u003cstrong\u003emaintenance\u003c/strong\u003e (practicing the behavior for at least 6 months)\u0026nbsp;[20]. This strategy will be used to classify the initial stage of patients and also to guide the professional responsible for the patient in the progression of stages over the 6 months (0, and 6 months of the RCT).\u003c/p\u003e\n\u003cp\u003ec) Diagnosis of DM2: confirmed by examination of HbA1c \u0026ge; 6.5% in the 3 months prior to the date of randomization; \u003cstrong\u003enote\u003c/strong\u003e: the inclusion criteria for use of medication (oral hypoglycemic agent or insulin) or clinical diagnosis will be disregarded due to redundancy, considering the following inclusion criteria.\u003c/p\u003e\n\u003cp\u003ed) * Difficult to manage DM2: recorded in medical records as such \u003cstrong\u003eOR\u003c/strong\u003e; recorded in medical records as a patient with poor medication adherence \u003cstrong\u003eOR\u003c/strong\u003e; one or more co-morbidities excluding cardiovascular disease (CVD); \u003cstrong\u003eOR\u003c/strong\u003e at least one episode of hypoglycemia requiring third-party help or hypoglycemic coma; \u003cstrong\u003eOR\u003c/strong\u003e one or more stable CVDs; \u003cstrong\u003eOR\u003c/strong\u003e one or more CV risk factors; \u003cstrong\u003eOR\u003c/strong\u003e one or more microvascular disorders (diabetic proliferative retinopathy excluded);\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003e\u003cem\u003eExclusion criteria\u003c/em\u003e\u003c/h3\u003e\n\u003cp\u003eParticipants who meet any of the following criteria will be excluded:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003ePregnant women (regardless of gestational DM);\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eHIV/AIDS;\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eUse of erythropoietin, volume loss, blood transfusion, or recent severe anemia;\u0026nbsp;\u003c/li\u003e\n \u003cli\u003ePatients with CVD on non-optimized treatment \u003cstrong\u003eOR\u003c/strong\u003e CVD procedure in the last 3 months; Proliferative macular disease associated with diabetes;\u0026nbsp;\u003c/li\u003e\n \u003cli\u003ePatients participating in another study at the same time;\u0026nbsp;\u003c/li\u003e\n \u003cli\u003ePatients residing with other patients enrolled in the D-CARE Study.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eInterventions for each group\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eIntervention group: behavior change\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eInterventions will occur in groups, with randomization into groups of 8 people. Patients randomized to the intervention group will attend 1 weekly meeting at their reference ESF/UBS or community unit connected to the territory, for 6 months. All patients in the study, as stated in the eligibility criteria, will be required to start in the pre-action stage (pre-contemplation, contemplation, or preparation), and professional psychologists will guide the group sessions with the intention of leading the participants to the stage of action/maintenance.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn the pre-contemplation, contemplation, and preparation phases, it is usually indicated that transitions can occur in 6, 6, and 1 month, respectively, however, the time for transition may be shorter and, at the discretion of the professional psychologist, a patient in contemplation, for example, can already switch to the action phase. Particularly in group interventions, the participants who follow through may be at different stages. There is also the possibility of relapses and recurrences, in which patients return to previous stages. Thus, for the pre-contemplation, contemplation, and preparation phases, patients are at the discretion of the psychologist to consider changing the phase (i.e., at this moment, the psychologist should apply the tool based on the guiding behavior question for reclassification of the patient\u0026apos;s behavior stage) and direction of content. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe professional responsible for group interventions must necessarily identify the particularities of each individual and direct the dynamics so that each individual contributes to the group with sensations, implications, challenges, and experiences according to the phase they are in. This happens on purpose, so that the group bond is not lost, and for patients in more advanced stages (or vice versa) to help their peers in the progression of stages. Tentatively, the professional will try to lead the group to evolve at the same pace, with therapeutic mechanisms to reach a balance. However, heterogeneity within the group is expected and is inherent to the type of intervention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLongitudinally, the behavior stages of the patients reclassified at 3 months and 6 months. During the study, after the participants understand the concept of self-care in DM, the following question will be repeated to the participants: \u0026quot; \u003cem\u003eDo you effectively practice diabetes self-care in your daily life?\u003c/em\u003e\u0026quot;\u0026nbsp;[19]. Five response categories will be available, placing participants in one of five stages of self-care: \u003cstrong\u003epre-contemplation\u0026nbsp;\u003c/strong\u003e(\u0026ldquo;\u003cem\u003enot intending to start in the next 6 months\u003c/em\u003e\u0026rdquo;), \u003cstrong\u003econtemplation\u003c/strong\u003e (\u0026ldquo;\u003cem\u003eintending to start in the next 6 months\u003c/em\u003e\u0026rdquo;), \u003cstrong\u003epreparation\u003c/strong\u003e (\u0026ldquo;\u003cem\u003enot intending to start in the next 30 days\u003c/em\u003e\u0026rdquo;), \u003cstrong\u003eaction\u003c/strong\u003e (\u003cem\u003epracticing the behavior, but for less than 6 months\u003c/em\u003e), or \u003cstrong\u003emaintenance\u003c/strong\u003e (\u003cem\u003epracticing the behavior for at least 6 months\u003c/em\u003e)\u0026nbsp;[20]. This strategy will be used to classify patients in their initial stage and also to guide the professional responsible for the patient in the progression of stages over the 6 months.\u003c/p\u003e\n\u003cp\u003eThe professional conducting the sessions should use the processes suggested by Prochaska and DiClemente for each given stage of behavior change. The processes are affective and emotional domains that approach the behavior to be changed - in our case, self-care - from different perspectives. For example, in the pre-contemplation stage, awareness, dramatic relief, reassessment of perceived environment, and self-reassessment are included, with weighting on the pros of adhering to an autonomous and decisional self-care routine.\u003c/p\u003e\n\u003cp\u003eFrom the 9th meeting, patients will receive visits from a multidisciplinary health team to address topics related to self-care, previously instructed and coordinated by a professional psychologist to respect the affective and emotional contents of each indicated process. This will help the professional who coordinates the group with the stage transition when addressing themes that, in the future, will be the target of action and maintenance, and that sometimes patients have already experienced in life as successful or failed experiences. At the end of each session, specific tasks will be given to the patients, which will be resumed in the next meeting. For patients in a period of action, specific and intensive recommendations will be given for each habit domain that makes up self-care, based on the \u003cem\u003eStandards of Medical Care of the American Diabetes Association\u003c/em\u003e 2021 (ADA) for self-care in DM2 and in the four domains of self-care in diabetes that involve blood glucose management, food and medication management, physical activity, and the use of health services. In the case of relapses, the patient will be reassessed by the study team to correctly identify which phase hey are in and resume the content according to their status and indications for relapse.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eControl group: usual care\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePatients randomized to the usual care group will follow their usual outpatient routine for the same duration of the study, but will be evaluated in the same way (outcomes, times, etc.) as patients in the intervention group. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eCriteria for discontinuation\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eParticipants will be required to complete a minimum of 22 of the 27 scheduled training sessions (i.e. \u0026gt;80% participation) during the 6-month intervention period.\u0026nbsp;If the patient misses a session, they will have the opportunity to complete an additional session to make up the missed training.\u0026nbsp;Adherence will be recorded through attendance sheets, which will be filled out after each training session by the coordinating researcher of the intervention group.\u003c/p\u003e\n\u003cp\u003eWith respect to the participants in the control group, they will be expected to attend the laboratory every time they are recruited, for the collection of biochemical tests every 3 months, and for the collection of other data after 6 months.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIf an adverse event is deemed to have a causal relationship to the intervention and raises concern about participant safety, the intervention will be discontinued for the participant.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eRelevant concomitant care and interventions\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTo ensure that the only difference between groups is the clinical trial intervention, participants will be instructed not to make any dietary changes or engage in any formal exercise program during the study.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTrial Status\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe initial protocol presented to the federal government in the project was longer, lasting 18 months (Protocol 1), and this version was applied to the pilot group that was not yet registered with Clinical Trials. As mentioned above, after seeing the pilot run and based on the literature, the protocol was adjusted to the version described here (Protocol 2). Therefore, the study was registered at www.clinicaltrials.gov, with the number NCT05969015 dated July 3, 2023, with recruitment starting in July and this phase expected to end in December 2023.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eOutcomes\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eFor the efficacy variable, the outcome used will be the maintenance of basal glycated hemoglobin control for 6 months. In addition, relevant clinical, functional, and behavioral outcomes will be considered at 6 months, including: estimating glycemic control, renal function, and lipid profile; estimating intercurrences attributable or not to DM2; estimating pressure control, body weight, anthropometry, adherence to pharmacological treatment; estimating total physical activity, in leisure, and in domestic and incidental activities; functional capacity, depression and anxiety scores; estimating adherence to the intervention; estimating the occurrence of behavior changes, their respective stages, and average times for occurrence; estimating the percentage of participants in action and/or maintenance at the end of 6 months; estimating the magnitude of changes in habits that make up the behavior; estimating the occurrence of adverse events of interest related or not to the study; developing a strategy for implementation of the protocol, if it proves to be effective, in all national primary care.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStage 5\u003c/em\u003e\u003c/strong\u003e - Finalization\u003c/p\u003e\n\u003cp\u003eFinalization of the RCT, reporting to CNPq and other entities, notification to the Unesc and HSJ Research Ethics Committee, closing of the register at www.clinicaltrials.gov, processing of the data, delivery of the results to the patients, delivery of the results to the municipal government and the funding body, CNPq, publication of the results on a non-peer-reviewed publication server (preprints), press-releases (in accordance with the study\u0026apos;s press-release policy) and preparation of the manuscript with the main results of the study.\u003c/p\u003e\n\u003cp\u003eStatistical Analysis Plan\u003c/p\u003e\n\u003cp\u003eDescriptive statistics will be presented in continuous and categorical data, accompanied by the respective dispersion measures. Hypothesis tests will be performed for inferential analysis. For all conclusions related to primary and secondary endpoints, the intention-to-treat principle will be used as the primary analysis, accompanied by per-protocol analyses. Generalized linear models or mixed effects models will be used depending on the pattern of \u003cem\u003emissing data\u003c/em\u003e found from the intra-unit variability. Three interim safety reviews will be scheduled, performed by an independent panel, for potential early termination due to harm, if this is the case, in accordance with the rules established by the study for patient safety. Stata 17.0.0 and R 4.3.1 statistical packages will be used for analysis, graphs, and figures.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe construction of a health system is a continuous process that involves the construction and change of public policies and social participation. In this sense, strategies are needed to reorient the care model, defined by Paim as \u0026ldquo;[...] a way of combining techniques and technologies to solve problems and meet individual and collective health needs. It is a reason for being, a rationality, a kind of \u0026apos;logic\u0026apos; that guides action\u0026quot;\u0026nbsp;[21]. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe action of the family health team aims to ensure integrality in health, which among its concepts means ensuring assistance, curative actions, and above all, prevention and health promotion. In this sense, health education is presented as a tool for reorienting the health care model and sharing therapeutic goals between the health team and the patient, presenting itself as an essential therapeutic strategy in the non-pharmacological treatment of chronic conditions.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe results pointed out by the IDF Diabetes Atlas, released in 2019, point out that there is still a long way to go in reducing the global impact of diabetes\u0026nbsp;[22]. Among the various therapeutic plans common to chronic diseases, health education stands out in the sense of making the individual the protagonist in the management of their health condition and self-care\u0026nbsp;[14]. However, promoting health care through health education strategies is still a major challenge for all levels of primary care.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAlthough educational practices are a good alternative to compose the care model for people with DM, studies show the low impact of these models on adherence to self-care. It is important that DM education be carried out based on models that promote the individual\u0026apos;s adherence to the care process and equip them to manage their condition\u0026nbsp;[23]. In this sense, the bond between educator and student as an effective strategy is important, promoting the co-responsibility of the student and the continuity and longitudinality of care.\u003c/p\u003e\n\u003cp\u003eEspecially for family health teams, work overload and the large number of outpatient procedures make it difficult to pay attention to preventive care strategies. In this way, innovative strategies that point to a reduction in the bureaucracy of care processes, such as the use of technologies in order to bring the health team closer to the family and the enrolled population, point to the agility of the processes.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn addition, with the change in the SUS financing model, the Previne Brasil program, within the incentive criteria for strategic actions, recommends via technical note n\u0026ordm; 7/2022-SAPS/MS, the definition of the proportion of people with diabetes, with a consultation and glycated hemoglobin requested within 6 months, and a goal established for this indicator of 50% of population coverage, since the glycated hemoglobin test allows estimation of the prognosis and performance of the appropriate therapeutic adjustment, with a view to reducing morbidity and mortality due to DM. Therefore, therapeutic plans that enhance the strategies to achieve this goal, directly contribute to the strengthening of PHC and its ability to resolve chronic conditions.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was performed in line with the principles of the Declaration of Helsinki. The study is approved by the Research Ethics Committee of the University of Extremo Sul Catarinense and all participants will provide their written informed consent (registration number 48193721.0.0000.0119 and approval number 4.805.666). Test results will be disseminated through peer-reviewed journal articles and conference presentations, reports to organizations involved in PD, and to participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll participants consented to participation in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests,\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot aplicaded\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualization: Luciane Bisognin Ceretta, Lucas Helal and Andriele Vieira; Writing \u0026ndash; original draft: Vanessa Iribarrem Avena Miranda; Lucas Helal; Andriele Vieira; Lisiane Generoso Tuon; Joni Marcio de Farias. Writing (review and editing): Vanessa Iribarrem Avena Miranda and Cristiane Damiani Tomasi. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe authors thank the Universidade do Extremo Sul Catarinense (UNESC) and Conselho Nacional de Desenvolvimento Cient\u0026iacute;fico e Tecnol\u0026oacute;gico\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eInternational Diabetes Federation (IDF). Diabetes Atlas. 7th Edition, International Diabetes Federation, Brussels, Belgium. 2015.\u003c/li\u003e\n\u003cli\u003eAmerican Diabetes Association. Diagnosis and classification of diabetes mellitus. 2010, 33, Suppl 1: S62-S69. doi: 10.2337/dc10-S062\u003c/li\u003e\n\u003cli\u003eCorr\u0026ecirc;a K, Gouv\u0026ecirc;a GR, Silva MAV, Possobon RF, Barbosa LFLN, Pereira AC et al. Qualidade de vida e caracter\u0026iacute;sticas dos pacientes diab\u0026eacute;ticos. Ci\u0026ecirc;nc. sa\u0026uacute;de colet. 2017; 22:921-930. doi: 10.1590/1413-81232017223.24452015\u003c/li\u003e\n\u003cli\u003eWorld Health Organization (WHO). Global report on diabetes: executive summary. In\u003cem\u003e.\u003c/em\u003e: World Health Organization. 2016.\u003c/li\u003e\n\u003cli\u003eSchmidt MI, Hoffmann JF, de F\u0026aacute;tima Sander Diniz M, Lotufo PA, Griep RH, Bensenor IM et al. High prevalence of diabetes and intermediate hyperglycemia - The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). Diabetol Metab Syndr. 2014; 6:1-9. doi: 10.1186/1758-5996-6-123\u003c/li\u003e\n\u003cli\u003eInstituto Brasileiro de Geografia e Estat\u0026iacute;stica (IBGE). Pesquisa nacional de sa\u0026uacute;de 2019: percep\u0026ccedil;\u0026atilde;o do estado de sa\u0026uacute;de, estilos de vida, doen\u0026ccedil;as cr\u0026ocirc;nicas e sa\u0026uacute;de bucal: Brasil e grandes regi\u0026otilde;es [Internet]. Rio de Janeiro: IBGE. 2020.\u003c/li\u003e\n\u003cli\u003eGBD 2017 Causes of Death Collaborators. Global, regional, and national age-sex-specific mortality for 282 causes of death in 195 countries and territories, 1980-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018; 392(10159):1736-1788. doi: 10.1016/S0140-6736(18)32203-7\u003c/li\u003e\n\u003cli\u003eMinist\u0026eacute;rio da Sa\u0026uacute;de (Brasil). DATASUS\u0026mdash;Departamento de Inform\u0026aacute;tica do SUS. Indicadores de Mortalidade [Internet]. [cited 2023 Jan 22]. Available from: http://tabnet.datasus.gov.br/cgi/deftohtm.exe?sim/cnv/obt10uf.def.\u003c/li\u003e\n\u003cli\u003eInstitute for Health Metrics and Evaluation (IHME). Epi Visualization. Seattle, WA: IHME, University of Washington, 2020. Available from: https://vizhub.healthdata.org/epi/\u003c/li\u003e\n\u003cli\u003eInstitute for Health Metrics and Evaluation (IHME). Causes of Death. Seattle, WA: IHME, University of Washington, 2020. Available from: https://vizhub.healthdata.org/cod/\u003c/li\u003e\n\u003cli\u003eInstitute for Health Metrics and Evaluation (IHME). Health Data. Seattle, WA: IHME, University of Washington, 2020. Available from: http://www.healthdata.org/brazil \u003c/li\u003e\n\u003cli\u003eRosa MQM, Rosa RDS, Correia MG, Araujo DV, Bahia LR, Toscano CM. Disease and Economic Burden of Hospitalizations Attributable to Diabetes Mellitus and Its Complications: A Nationwide Study in Brazil. Int J Environ Res Public Health. 2018, 15(2):294. doi: 10.3390/ijerph15020294\u003c/li\u003e\n\u003cli\u003eToscano CM, Sugita TH, Rosa MQM, Pedrosa HC, Rosa RDS, Bahia LR. Annual Direct Medical Costs of Diabetic Foot Disease in Brazil: A Cost of Illness Study. Int J Environ Res Public Health. 2018; 15(1): 89. doi: 10.3390/ijerph15010089\u003c/li\u003e\n\u003cli\u003eForti A, Pires A, Pittito B, Gerchman F, Oliveira J, Zajdenverg LJ. Diretrizes da Sociedade Brasileira de Diabetes 2019-2020 [Internet]. 2020.\u003c/li\u003e\n\u003cli\u003eProchaska JM, Prochaska JO, Levesque DA. A transtheoretical approach to changing organizations. Adm Policy Ment Health. 2001; 28(4):247-262. doi: 10.1023/a:1011155212811 \u003c/li\u003e\n\u003cli\u003eMcKee G, Bannon J, Kerins M, FitzGerald G. Changes in diet, exercise and stress behaviours using the stages of change model in cardiac rehabilitation patients. Eur J Cardiovasc Nurs. 2007; 6(3):233-240.doi: 10.1016/J.EJCNURSE.2006.10.002\u003c/li\u003e\n\u003cli\u003eMachado MFAS, Monteiro EMLM, Queiroz DT, Vieira NFC, Barroso MGT. Integralidade, forma\u0026ccedil;\u0026atilde;o de sa\u0026uacute;de, educa\u0026ccedil;\u0026atilde;o em sa\u0026uacute;de e as propostas do SUS: uma revis\u0026atilde;o conceitual. 2007, 12:335-342. doi: 10.1590/S1413-81232007000200009\u003c/li\u003e\n\u003cli\u003eSchmitt A, Gahr A, Hermanns N, Kulzer B, Huber J, Haak T. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes. 2013; 11:1-14. doi: 10.1186/1477-7525-11-138\u003c/li\u003e\n\u003cli\u003eVelicer WF., Prochaska JO, Fava JL, Norman, GJ, Redding CA. (1998). Smoking cessation and stress management: Applications of the transtheoretical model of behavior change. Homeostasis in Health and Disease, 38(5-6), 216\u0026ndash;233. https://psycnet.apa.org/record/1998-12149-001\u003c/li\u003e\n\u003cli\u003eEvers KE, Prochaska JO, Johnson JL, Mauriello LM, Padula JA, Prochaska JM. A randomized clinical trial of a population-and transtheoretical model-based stress-management intervention. Health Psychol. 2006; 25(4):521. doi: 10.1037/0278-6133.25.4.521\u003c/li\u003e\n\u003cli\u003ePaim JS. A reforma sanit\u0026aacute;ria e os modelos assistenciais. In: \u003cem\u003eEpidemiologia \u0026amp; sa\u0026uacute;de.\u003c/em\u003e edn.; 1993: pp 455-466.\u003c/li\u003e\n\u003cli\u003eInternational Diabetes Federation (IDF) (2015) Diabetes Atlas. 7th Edition, International Diabetes Federation, Brussels, Belgium. 2019. \u003c/li\u003e\n\u003cli\u003eBorges SAC, Porto PN. Por que os pacientes n\u0026atilde;o aderem ao tratamento? Dispositivos metodol\u0026oacute;gicos para a educa\u0026ccedil;\u0026atilde;o em sa\u0026uacute;de. Sa\u0026uacute;de debate. 2014; 38:338-346. doi: 10.5935/0103-1104.20140031\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Primary Care, Diabetes Mellitus Type 2, Health education, Self-care, Behavior change, Glycemic Control","lastPublishedDoi":"10.21203/rs.3.rs-3249763/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3249763/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective\u003c/strong\u003e: Testing a model of Health Education and self-care, based on the transtheoretical model of behavior change by Prochaska and DiClemente, on glycemic control, and important clinical and behavioral variables, against usual care, in patients with difficult-to-manage Type 2 Diabetes Mellitus.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: randomized, parallel, phase III clinical trial, with allocation ratio of 1:1, duration of 6 months, with primary endpoint HbA1c (%) between groups at the end of 6 months. The RCT will be conducted in the assigned territory of the patients, in order to reinforce the student-educator bond and the adherence of patients to the trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis Plan\u003c/strong\u003e: descriptive analyses will be presented in continuous and categorical data, accompanied by the respective dispersion measures. Hypothesis tests will be performed for inferential analysis. For all conclusions related to primary and secondary endpoints, the intention-to-treat principle will be used as the primary analysis, accompanied by per-protocol analyses. Generalized linear models or mixed effects models will be used depending on the pattern of \u003cem\u003emissing data\u003c/em\u003e found arising from intra-unit variability. Three interim safety reviews will be scheduled, performed by an independent panel, for potential early termination due in the case of harm, in accordance with the rules established by the study for patient safety. Stata 17.0.0 and R 4.3.1 statistical packages will be used for analysis, graphs, and figures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTest registration number: \u003c/strong\u003eBrazilian Registry of Clinical Trials (RBR-5w2sqt); Pre-results.\u003c/p\u003e","manuscriptTitle":"Health education and self-care in primary health care in patients with type 2 diabetes mellitus: protocol for a randomized clinical trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-01-02 19:18:25","doi":"10.21203/rs.3.rs-3249763/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"8b72e7bc-9083-4833-8569-a92f0346e396","owner":[],"postedDate":"January 2nd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-01-22T20:24:01+00:00","versionOfRecord":[],"versionCreatedAt":"2024-01-02 19:18:25","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-3249763","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3249763","identity":"rs-3249763","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}